Completed

Maridebart Cafraglutide for Weight Loss in Overweight or Obesity with or without Type 2 Diabetes

Study Aim

This study aims to evaluate the effectiveness of Maridebart Cafraglutide for weight loss in overweight or obese individuals, with or without Type 2 Diabetes, by measuring the percent change in body weight from the start to the 52nd week.

What is being tested

Maridebart Cafraglutide

+ Placebo

BiologicalDrug

Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 99 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: January 2023

See protocol details

Summary

Principal SponsorAmgen

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 18, 2023

Actual date on which the first participant was enrolled.

This study focuses on a treatment called AMG 133, also known as maridebart cafraglutide. The main goal is to see how well this treatment helps adults with overweight or obesity lose weight and keep it off for a year. The study includes two groups: one with overweight or obesity but no diabetes, and another with overweight or obesity and Type 2 diabetes. The aim is to find the right dose that works best and is safe for both groups. This research is important as it could lead to a new way to manage weight and potentially improve health outcomes for those with obesity or Type 2 diabetes. During the study, participants receive either AMG 133 or a placebo, a substance that looks like the real treatment but doesn't contain any active ingredients. The study measures the percentage of weight loss from the start to the end of the study, which lasts 52 weeks. This helps researchers understand if AMG 133 is effective in helping people lose weight. It's also a way to check the safety and tolerability of the treatment, ensuring it doesn't cause harm or discomfort to the participants.

Official TitleA Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

NCT05669599

Principal SponsorAmgen

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

592 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

Inclusion Criteria: * Age ≥18 years at the time of signing informed consent. * BMI ≥30 kg/m\^2, or ≥27 kg/m\^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. * For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label. * History of at least one unsuccessful dietary effort to lose body weight. Exclusion Criteria: * Change in body weight greater than 5 kg within 3 months prior to screening. * Obesity induced by other endocrinologic disorders. * History of pancreatitis. * Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2). * History of major depressive disorder within the last 2 years. * Any lifetime history of other major psychiatric disorder or suicide attempt.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.

Group II

Placebo

Part 1: Cohort A will consist of participants without a diagnosis of type 1 or type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 7 dose cohorts . Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.

Group III

Experimental

Part 1: Cohort B will consist of participants with a diagnosis of type 2 diabetes mellitus. Participants will be randomized to receive maridebart cafraglutide or placebo in 1 of 4 dose cohorts. Participants will then have the option to begin part 2 if they meet the entry criteria. Part 2: Participants that continue into part 2 will be re-randomized to receive maridebart cafraglutide or Placebo in 1 of 4 dose cohorts.

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 78 locations

Suspended

HonorHealth

Scottsdale, United StatesOpen HonorHealth in Google Maps

Suspended

Baker Heart and Diabetes Institute

Melbourne, Australia

Suspended

University of Calgary

Calgary, Canada

Suspended

Centricity Research Brampton Endocrinology

Brampton, Canada

Completed78 Study Centers