Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Participants With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus

• Status: Not yet recruiting
• Trial end date: 2024-12-29
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to compare and assess the dose response of 3 selected doses of AMG 133 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 diabetes mellitus (Cohort B).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

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.