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

Purpose

The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).

Conditions

  • Obesity
  • Overweight
  • Type 2 Diabetes Mellitus

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort A: Maridebart Cafraglutide 		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.
  • Biological: Maridebart Cafraglutide
    Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
    Other names:
    • AMG 133
  • Drug: Placebo
    Participants will receive placebo by SC injection.
Placebo Comparator
Cohort A: 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.
  • Biological: Maridebart Cafraglutide
    Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
    Other names:
    • AMG 133
  • Drug: Placebo
    Participants will receive placebo by SC injection.
Experimental
Cohort B: Maridebart Cafraglutide 		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.
  • Biological: Maridebart Cafraglutide
    Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
    Other names:
    • AMG 133
  • Drug: Placebo
    Participants will receive placebo by SC injection.
Placebo Comparator
Cohort B: Placebo 		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.
  • Biological: Maridebart Cafraglutide
    Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
    Other names:
    • AMG 133
  • Drug: Placebo
    Participants will receive placebo by SC injection.

Recruiting Locations

More Details

NCT ID
NCT05669599
Status
Active, not recruiting
Sponsor
Amgen

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center