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

ConditionOverweight or Obesity and Elevated Liver Fat
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Body Mass index (BMI) ≥ 27 kg/m² to ≤ 40 kg/m² 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maridebart cafraglutide

    Drug

    Maridebart cafraglutide will be administered as a SC injection.

  • Placebo

    Drug

    Placebo will be administered as a SC injection.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Maridebart CafraglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and Week 52
2

Percent Change from Baseline in Body Weight at Week 52

Time frame
Baseline and Week 52

Secondary outcomes

1

Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52

Time frame
Baseline and Week 52
2

Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52

Time frame
Baseline and Week 52
3

Number of Participants Achieving < 5% LFC by MRI at Week 52

Time frame
Week 52
4

Change from Baseline in LFC by MRI at Week 52

Time frame
Baseline and Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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