Clinical Research

Furthering science, research & medical developments.

Florida Medical Clinic Orlando Health is proud to make a difference by conducting innovative clinical trials to further clinical advancement. Numerous clinical research studies are conducted on an ongoing basis to help further science, research and medical development.

New and exceptional medications waiting for FDA approval are tested in our Clinical Research Department. Nationwide patient results are monitored and evaluated by the FDA in an effort to constantly improve medical treatments. The study length varies according to the test criteria.

Your physician can advise you about your eligibility for clinical research. Medical care, medications, and possible compensation are available to qualified patients who volunteer for a clinical trial.

Contact Us

If you would like additional information on any study listed, please contact:

William D. Johnston RN CCRC
(813) 780-8368
wjohnston@floridamedicalclinic.com

Our Current Clinical Trials

Study Title

A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Associated Steatohepatitis (NASH/MASH) and (F2) – (F3) Stage of Liver Fibrosis

Protocol Name: LIVERAGE

Protocol Number: 1404-0044

Description: This study is open to adults who are at least 18 years old and have:

• a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic-associated steatohepatitis (MASH) and
• moderate or advanced liver fibrosis

People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.

This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function.

Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.

The doctors check participants’ health and take note of any unwanted effects. The participants’ body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.

Eligibility: Inclusion criteria:

1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent

2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD) activity score [NAS] ≥4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F2-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomisation

3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used

4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial

5. Further inclusion criteria apply

Exclusion criteria:

1. Any of the following liver laboratory test abnormalities at screening:

• Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)
• Platelet count <140 000/mm^3 (<140 GI/L)
• Alkaline phosphatase >2x upper limit of normal (ULN)
• Abnormal synthetic liver function as defined by screening central laboratory evaluation:
  • Albumin below <3.5 g/dL (35.0 g/L)
  • OR International normalised ratio (INR) of prothrombin time >1.3 (unless participant is on anticoagulants)
  • OR total serum bilirubin concentration ≥1.5x ULN (participants with a documented history of Gilbert’s syndrome can be enrolled if the direct bilirubin is within normal reference range)

2. Any history or evidence of acute or chronic liver disease other than MASH

3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy

4. History of or current diagnosis of hepatocellular carcinoma

5. History of or planned liver transplant

6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.

7. History of portal hypertension or presence of decompensated liver disease (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis)

8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease.

9. Treatment with any medication for the indication obesity within 3 months before screening biopsy or historical biopsy time point

10. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x ULN as measured by the central laboratory at screening

11. Major surgery (in the opinion of the investigator) performed within 3 months prior to screening or planned during the trial

12. Further exclusion criteria apply

Start Date: October 14, 2024

Projected End Date: December 27, 2031

ClinicalTrials.gov Identifier: NCT06632444

Study Web Address for Potential Patients: N/A

Study Title

A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis

Protocol Name: LIVERAGE

Protocol Number: 1407-0064

Description: This study is open to adults who are at least 18 years old and have:

• A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or
• A confirmed liver disease called metabolic-associated steatohepatitis (MASH)
• BMI of 27 kg/m2 or more or
• 25 kg/m2 or more if the participant is Asian.

People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.

Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.

The doctors check participants’ health and take note of any unwanted effects. The participants’ body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Eligibility: Inclusion criteria:

1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is >18 years

2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)

3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis diagnosed according to modified Liver Forum criteria (Noureddin et al, Gastroenterology 2020;159:422-427).

4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF or FibroScan® with CAP ≤12 weeks prior to randomisation (except for patients with ‘cryptogenic cirrhosis’ where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.

5. Further inclusion criteria apply.

Exclusion criteria:

1. Current or history (<5 years) of significant alcohol consumption, defined as an average of >140 g/week in female patients and >210 g/week in male patients, for a period of >3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.

2. Model of end-stage liver Disease (MELD) score >12 due to liver disease

3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:

• History of portal hypertension-related upper gastrointestinal (GI) bleeding
• Ascites
• Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria

4. Any of the following lab test result at screening

• Albumin below <3.5 g/dL (<35.0 g/L)
• International normalised ratio (INR) >1.3 unless due to therapeutic anticoagulants
• Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is <20% of TBL.
• Alkaline phosphatase >1.5x ULN
• Platelet count <100,000/µL (<100 GI/L)

5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson’s disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis

6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg))

7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))

8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN

9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history

10. History of liver transplantation or listed for liver transplantation

11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment

12. Further exclusion criteria apply

Start Date: November 12, 2024

Projected End Date: June 5, 2029

ClinicalTrials.gov Identifier: NCT06632457

Study Web Address for Potential Patients: N/A

Study Title

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease

Protocol Name: TARGET-CD

Protocol Number: M24-885

Description: Crohn’s disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.

The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.

Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.

There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

Eligibility: Inclusion Criteria:

• Participants’ body weight must be ≥ 40 kg at Baseline.
• Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
• CDAI ≥ 220 at Baseline.
• Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
• Participants must demonstrate intolerance or inadequate response to TaTs including biologics

Exclusion Criteria:

• Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
• Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
• Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.

Start Date: September 4, 2024

Projected End Date: August 2028

ClinicalTrials.gov Identifier: NCT06548542

Study Web Address for Potential Patients:  https://www.ibdiscoveradultstudies.com/

Study Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Protocol Name: Synchrony Outcomes

Protocol Number: AK-US-001-0106

Description: This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Eligibility: Inclusion Criteria:

• Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
• Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion Criteria:

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
• Type 1 diabetes or unstable Type 2 diabetes
• Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply

Start Date: September 4, 2024

Projected End Date: October 2029

ClinicalTrials.gov Identifier: NCT06528314

Study Web Address for Potential Patients: N/A

Study Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Protocol Name: Synchrony Histology

Protocol Number: AK-US-001-0105

Description: This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).

The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Eligibility: Inclusion Criteria:

• Males and non-pregnant, non-lactating females between 18 – 80 years of age inclusive, based on the date of the screening visit.
• Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
• Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
  • Steatosis (scored 0 to 3),
  • Ballooning degeneration (scored 0 to 2), and
  • Lobular inflammation (scored 0 to 3).

Exclusion Criteria:

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
• Presence of cirrhosis on liver biopsy (fibrosis stage 4).
• Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Start Date: December 1, 2023

Projected End Date: November 2032

ClinicalTrials.gov Identifier: NCT06215716

Study Web Address for Potential Patients: N/A

Study Title

A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Protocol Name: AMETRINE 1

Protocol Number: GA45329

Description: This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Eligibility: Inclusion Criteria:

• Confirmed diagnosis of UC
• Moderately to severely active UC assessed by mMS
• Bodyweight >= 40 kilogram (kg)
• Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
• Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

• Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
• Current diagnosis of Crohn’s disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
• Presence of an ostomy or ileoanal pouch
• Current diagnosis or suspicion of primary sclerosing cholangitis
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study
• Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
• History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
• Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
• Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
• Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Start Date: September 17, 2024

Projected End Date: December 30, 2029

ClinicalTrials.gov Identifier: NCT06589986

Study Web Address for Potential Patients: N/A

Study Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 Fibrosis

Protocol Name: FASCINATE-3

Protocol Number: SB2640-CLIN-010

Description: A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis.

Eligibility: Inclusion Criteria:

1. Willing and able to participate in the study and provide written informed consent.
2. Adults between 18 and 75 years of age.
3. Body mass index (BMI) ≥23 kg/m^2 for Asian patients and ≥25 kg/m^2 for patients of other races.
4. Presence of metabolic risk factor(s), as follows:
   • T2DM.

OR

1. • 2 out of 4 of the following:
     1. BMI ≥30 kg/m^2.
     2. Hypertension, or on active antihypertensive treatment.
     3. Elevated fasting serum TGs or on active treatment for hypertriglyceridemia.
     4. Reduced fasting serum HDL-c or on active treatment for dyslipidemia.
2. For patients with T2DM:
   1. HbA1c ≤9.5%.
   2. Metformin, insulin, dipeptidyl peptidase-4 inhibitors (DPP4-Is), sodium-glucose transport protein-2 inhibitors (SGLT2-Is), and alpha-glucosidase inhibitors (α-GIs): stable dose for at least 12 weeks prior to qualifying liver biopsy and screening.
   3. Sulfonylureas (SUs) and glinides: stable dose with no history of relevant hypoglycemia for at least 12 weeks prior to qualifying liver biopsy and screening.
   4. GLP-1 RA: stable dose for at least 18 weeks prior to start of screening.
3. Noncirrhotic, biopsy-proven MASH with:
   1. A fibrosis stage of F2 or F3.
   2. NAS ≥4 with at least a score of 1 in each of the following NAS components:
      1. Steatosis (scored 0 to 3).
      2. Hepatocyte ballooning (scored 0 to 2).
      3. Lobular inflammation (scored 0 to 3).
4. A qualifying historical liver biopsy within 6 months before the screening visit. Historical biopsy results will be confirmed by central reading.  If there is no available historical liver biopsy within this time period, a liver biopsy must be performed during the screening period. Patients should be deemed likely to have MASH F2/F3 fibrosis prior to proceeding to a liver biopsy, as indicated by the following:
   1.  FibroScan.
      1. Liver stiffness measurement (LSM) ≥8.5 kPa.
      2. Controlled attenuation parameter (CAP) ≥280 dB/m.
   2. Aspartate aminotransferase (AST) >20 U/L.
5. Stable ALT and AST levels.

Exclusion Criteria:

1. Previous intake of an approved MASH medication.
2. Exclusionary laboratory values:
   1. ALT and/or AST >5 × ULN.
   2. ALP ≥2 × ULN.
   3. Total serum bilirubin concentration >1.3 mg/dL.
   4. Serum albumin concentration <3.5 g/dL.
   5. INR >1.3 except for patients receiving anticoagulant treatment.
   6. Platelet count <140,000/μL.
   7. Fasting TG level ≥500 mg/dL.
   8. eGFR <45 mL/min/1.73 m^2.
3. History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
4. Presence of cirrhosis on liver histology according to the assessment of the central reader.
5. Current or historical clinically evident hepatic decompensation.
6. Evidence of another form of active liver disease.
7. Positive serologic evidence of current infectious liver disease.
8. MELD score ≥12.
9. Planned or history of liver transplantation.
10. Prior or planned bariatric surgery.
11. Gain or loss of >5% of body weight in the 3 months or >10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
12. Any of the following within 6 months prior to the baseline visit (V1):
    1. Myocardial infarction.
    2. CABG/PTCA.
    3. Unstable angina.
    4. Transient ischemic attack, stroke, or cerebrovascular disease.
13. Unstable or undiagnosed arrhythmias.
14. Uncontrolled high BP.
15. Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
16. Any current or history of hepatocellular carcinoma
17. Diabetes other than T2DM.
18. Uncontrolled hypothyroidism.
19. Any other known serious disease or other disease which in the Investigator’s opinion would exclude the patient from participating in the study.
20. Previous intake of an approved MASH medication, unless there is at least a 6-month wash-out period between the last date of intake of the approved MASH medication and date of screening.
21. Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to the qualifying liver biopsy and screening.

Start Date: March 2025

Projected End Date: December 2030

ClinicalTrials.gov Identifier: NCT06594523

Study Web Address for Potential Patients: N/A

Study Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Protocol Name: FASCINIT

Protocol Number: SB2640-CLIN-011

Description: A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.

Eligibility: Inclusion Criteria:

1. Willing and able to participate in the study and provide written informed consent.
2. Adults between 18 and 75 years of age.
3. Body mass index (BMI) ≥23 kg/m2 for Asian patients and ≥25 kg/m2 for patients of other races.
4. Presence of metabolic risk factor(s), as follows:
   • • T2DM

   OR

   • At least 2 out of 4 of the following
     • BMI ≥30 kg/m2,
     • Hypertension, or on active antihypertensive treatment
     • Elevated fasting serum TGs or on active treatment for hypertriglyceridemia
     • Reduced fasting serum HDL-c, or on active treatment for dyslipidemia.
5. For patients with T2DM:
   1. 1. HbA1c ≤9.5%
      2. If treatment naive: patients must have been diagnosed for at least 12 weeks prior to screening
6. Suspected or confirmed diagnosis of MASH or MASLD or non-invasively diagnosed MASH or MASLD
7. Stable ALT and AST levels

Exclusion Criteria:

1. Previous intake of an approved MASH medication
2. Exclusionary laboratory values:
   1. ALT and/or AST >5 × ULN.
   2. ALP ≥2 × ULN.
   3. Total serum bilirubin concentration >1.3 mg/dL.
   4. Serum albumin concentration <3.5 g/dL.
   5. International normalized ratio (INR) >1.3, except for patients receiving anticoagulant treatment.
   6. Platelet count <140,000/μL.
   7. Fasting TG level ≥500 mg/dL.
   8. eGFR <45 mL/min/1.73 m2. 3. History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening. 4. Presence of cirrhosis on liver histology and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension. 5. Current or historical clinically evident hepatic decompensation. 6. Evidence of another form of active liver disease. 7. Positive serologic evidence of current infectious liver disease. 8. MELD score ≥12. 9. Planned or history of liver transplantation. 10. Prior or planned bariatric surgery. 11. Gain or loss of >5% of body weight in the 3 months or >10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
3. History of excessive alcohol intake for a period of more than 3 consecutive months within 1 year prior to screening.
4. Presence of cirrhosis on liver histology and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension.
5. Current or historical clinically evident hepatic decompensation.
6. Evidence of another form of active liver disease.
7. Positive serologic evidence of current infectious liver disease.
8. MELD score ≥12.
9. Planned or history of liver transplantation.
10. Prior or planned bariatric surgery.
11. Gain or loss of >5% of body weight in the 3 months or >10% of body weight in the 6 months prior to screening, qualifying liver biopsy, and the baseline visit (V1).
12. Any of the following conditions or procedures within 6 months prior to the baseline visit (V1):
    1. Myocardial infarction
    2. Cardiac revascularization surgery
    3. Unstable angina
    4. Transient ischemic attack, stroke, or cerebrovascular disease
13. Unstable or undiagnosed arrhythmias.
14. Uncontrolled high BP.
15. Malignancy with a complete remission date within 5 years prior to the baseline visit (V1).
16. Any current or history of hepatocellular carcinoma.
17. Diabetes other than T2DM
18. Uncontrolled hypothyroidism.
19. Any other known serious disease or other disease which in the Investigator’s opinion would exclude the patient from participating in the study.
20. Use of a nonpermitted concomitant medication within 30 days or 5 half-lives prior to screening.

Start Date:

Projected End Date:

ClinicalTrials.gov Identifier: NCT06692283

Study Web Address for Potential Patients: N/A

Study Title

A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis

Protocol Name: N/A

Protocol Number: PA0016

Description: The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA).

Eligibility: Inclusion Criteria:

· Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) ≥3 out of 68 joints and swollen joint count (SJC) ≥3 out of 66 joints (dactylitis of a digit counts as 1 joint each).

· Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).

· Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)

· Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naïve or have received not more than 1 prior tumor necrosis factor alpha (TNFα) inhibitor. Study participants who have been on a TNFα inhibitor previously must not have discontinued the TNFα inhibitor due to financial or health insurance reasons and must have either:

· experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or

· been intolerant to administration (eg, had a side-effect/adverse event (AE) that led to discontinuation).

Exclusion Criteria:

· Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.

· Female participants who are breastfeeding, pregnant, or plan to become pregnant during the study.

· Participant has an active infection or a history of recent serious infections.

· Participant has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.

· Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis.

· Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn’s disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.

· Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator’s opinion would have potential to interfere with efficacy assessments.

· Participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.

· Participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening.

· Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/ cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.

· Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit.

· Study participant is taking or has taken janus kinase (JAK) inhibitor.

· Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFα inhibitor.

· Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.

Start Date: October 21, 2024

Projected End Date: July 15, 2026

ClinicalTrials.gov Identifier: NCT06624228

Study Web Address for Potential Patients: N/A

Study Title

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study with Risankizumab As Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over with Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Protocol Name: IZAR-2

Protocol Number: M1095-PSA-302

Description: This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Eligibility: Inclusion Criteria:

1. Participants must be ≥18 years of age .

2. Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.

3. Participants have moderate to severe active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).

4. Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.

5. Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.

6. Participants must have received 1 or 2 TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with the TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.

2. Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients.

3. Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.

4. Participants with a diagnosis of inflammatory bowel disease.

5. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.

6. Participants who have an established diagnosis of arthritis mutilans.

7. Previous exposure to sonelokimab.

8. Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Start Date: October 15, 2024

Projected End Date: January 15, 2027

ClinicalTrials.gov Identifier: NCT06641089

Study Web Address for Potential Patients: N/A

Study Title

A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat, ACPA-Positive Rheumatoid Arthritis

Protocol Name: N/A

Protocol Number: IMVT-1402-2601

Description: This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA). The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response.

Eligibility: Inclusion Criteria:

• Diagnosis of ‘definite RA’ according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
• Greater than or equal to 6/68 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
• C-reactive protein ≥ 1.5 × upper limit of normal (ULN) at Screening Visit.
• DAS28-CRP > 4.1 at the Screening Visit.
• Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
• Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs.

Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

• · Have received rituximab and experienced insufficient efficacy or loss of efficacy
• History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA.
• Active malignancy or history of malignancy within 5 years prior to Screening Visit.
• Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
• Used any non-immunosuppressive Fc-based therapeutic protein (e.g., mAb or Fc-fusion protein) within 4 weeks prior to or at Screening Visit.
• Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.

Other, more specific exclusion criteria are defined in the protocol.

Start Date: December 2024

Projected End Date: September 2027

ClinicalTrials.gov Identifier: NCT06754462

Study Web Address for Potential Patients: N/A