Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Phase 2

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight

NCT07441252 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 2
Started
2026-03-05
Last updated
2026-09-28

Condition(s) studied

Overweight or Obesity and Elevated Liver Fat

Investigational drug(s) / intervention(s)

Maridebart cafraglutide →Placebo

Maridebart cafraglutide: Maridebart cafraglutide will be administered as a SC injection.

Placebo: Placebo will be administered as a SC injection.

Study summary

The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years. * Body Mass index (BMI) ≥ 27 kg/m\^2 to ≤ 40 kg/m\^2 at screening. * For participants with type 2 diabetes mellitus (T2DM) at screening: * HbA1c ≤ 9.5% (80 mmol/mol) at screening. * Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination. * Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment. * Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening. * MRI assessment should only be performed after all other eligibility has been confirmed whenever possible. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Exclusion Criteria: * Recent or planned surgical/device-based obesity treatment (\<1 year). * History of malignancy within the past 5 years (exceptions apply). * Type 1 diabetes or non-type 2 diabetes mellitus (T2DM); unstable/severe hypoglycemia. * Advanced diabetic retinopathy or macular edema. * History of pancreatitis (acute \<180 days or chronic). * History of medullary thyroid carcinoma (MTC) or MEN-2 * Major cardiovascular event within 60 days (e.g., myocardial infarction \[MI\], stroke, coronary artery bypass graft \[CABG\]). * New York Heart Association (NYHA) Class IV heart failure. * Unstable psychiatric disorders within 2 years. * Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) (e.g., hepatitis, cirrhosis, hepatic decompensation). * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2 or on dialysis. * Patient Health Questionnaire-9 (PHQ-9) ≥ 15, or suicidal ideation/behavior (Columbia-Suicide Severity Rating Scale \[C-SSRS\]). * Inability to undergo MRI scan (e.g., due to metal implant, claustrophobia, or body size limitations).

Primary outcome measure(s)

  • Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52 — Baseline and Week 52
  • Percent Change from Baseline in Body Weight at Week 52 — Baseline and Week 52

Trial sites (23)

FacilityCityRegionStatus
Arizona Clinical Trials Chandler Arizona
Medical Advancement Centers of Arizona Phoenix Arizona
Del Sol Research Management Tucson Arizona
San Fernando Valley Health Institute Canoga Park California
Gastroenterology and Liver Institute Escondido California
Inland Empire Liver Foundation Rialto California
Apex Clinical Research San Diego California
University of Florida College of Medicine-Jacksonville Gainesville Florida
Floridian Clinical Research LLC Miami Lakes Florida
Indago Research and Health Center Miami Lakes Florida
Gastrointestinal Specialists- Louisiana Research Center- Highland Shreveport Louisiana
Woodholme Gastroenterology Associates - Glen Burnie Glen Burnie Maryland
Alliance for Multispecialty Research - Kansas City Kansas City Missouri
Excel Clinical Research Las Vegas Nevada
Bellaire Clinical Research Bellaire Texas
Juno Research LLC Bellaire Texas
Pinnacle Clinical Research - Corpus Christi Corpus Christi Texas
South Texas Research Institute Edinburg Texas
Houston Research Institute Houston Texas
Houston Research Institute - Pasadena Pasadena Texas
McAllen Research Pharr Texas
American Research Corporation at the Texas Liver Institute San Antonio Texas
Pinnacle Clinical Research San Antonio Texas
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07441252 on ClinicalTrials.gov ↗ ← All trials in the USA