Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM

NCT06005012 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: NRC-2023-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Conduct a community intervention study that will 1) validate a screening approach to identify patients at risk for advanced NAFLD in the obese or T2DM population, and 2) test whether semaglutide treatment is effective for the management of significant fibrosis due to NAFLD in high-risk patients.

Conditions

Fibrosis, Liver; Type 2 Diabetes Mellitus in Obese; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Change in fibrosis due to NAFLD

  Change in fibrosis due to Nonalcoholic fatty liver disease (NAFLD), as measured by change in FAST Score, which combines FibroScan results with aspartate aminotransferase (AST).

  52 weeks

Secondary Outcomes (3)

• Change in liver stiffness

  52 weeks

• Change in steatosis

  52 weeks

• Change in ALT

  52 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing Semaglutide 3.0 mg/ml for subcutaneous use

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

2.4 mg weekly for 52 weekly in a 3 ml PDS290 pen-injector containing 3.0 mg/ml of a placebo solution for subcutaneous use

Drug: Placebo

Interventions

Semaglutide DRUG

Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) that is FDA-approved for the treatment of obesity (as Wegovy) or T2DM (as Ozempic).

Semaglutide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult, age ≥ 40 and \< 80 years
• Participant must meet at least one of following sets of conditions:
• BMI ≥ 27 kg/m² OR
• BMI ≥ 25 kg/m² AND presence of i) pre-diabetes (HbA1C ≥ 5.7) or ii) type 2 diabetes mellitus (T2DM), as defined by the American Diabetes Association (ADA) clinical practice recommendations.
• The ADA definition of T2DM is applicable if one of the following criteria is met:
• Presence of diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight loss, blurred vision) and casual plasma glucose ≥ 200 mg/dL (11.1 mmol/L)
• Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/L)
• Plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during a 75-g oral glucose tolerance test (OGTT)⁶⁸. If any of the above test results occur, testing should be repeated on a different day to confirm the diagnosis.
• Hemoglobin A1C (HbA1C) ≥ 6.5% ⁶⁹.
• FAST score ≥ 0.5 and VCTE ≥ 8.0 kPa; FAST score threshold based on data from MAESTRO-NASH trial⁴²; VCTE cutpoint based on AASLD guidelines for identification of patients with significant fibrosis risk.
• Participants without a VCTE assessment in their medical record may qualify for the study if they have a FIB-4 ≥ 1.0, which is a cutpoint based on observations of patients with T2DM in Ajmera et al³⁰, and VCTE ≥ 8.0 kPa.
• The subject is fully informed and willing and able to perform all the procedures specified in the protocol and has signed a written informed consent to participate

You may not qualify if:

• Presence of regular and/or excessive use of alcohol, defined as \> 30 g/day for males and \> 20 g/day for females, for a period longer than 2 years at any time in the last 10 years
• Evidence of cirrhosis or previously known cirrhosis, based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
• VCTE ≥ 20 kPa
• Platelet count ≤ 140,000 per Ml
• Albumin \< 3.6 g/dL
• INR \> 1.35, unless on coumadin for another indication
• Serum creatinine \> 2.0 mg/dL
• eGFR \< 30 mL/min/1.73 m² as defined according to the CKDEPI creatinine equation⁷⁰
• Use of other weight loss medications, including GLP1RA within the last 90 days
• Greater than 10% weight loss in the prior six months
• Known or suspected hypersensitivity to GLP1RA medications including semaglutide
• History of bariatric surgery within the past 5 years or expected bariatric surgery
• Evidence of other causes of chronic liver disease including:
• Hepatitis B, as defined as presence of hepatitis B surface antigen (HBsAg).
• Previous or current infection with Hepatitis C, as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver

Study Officials

• Rohit Loomba

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Egbert Madamba

CONTACT

(858) 246-2227; emadamba@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 22, 2023
• Study Start: July 25, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)