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

Launched by AMGEN · Dec 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called maridebart cafraglutide to see how well it helps people with overweight or obesity lose and maintain weight over a year. The trial includes two groups: one with participants who do not have diabetes and another with participants who have type 2 diabetes. Researchers will compare different doses of the medication to a placebo, which is a treatment that looks like the medication but doesn't contain any active ingredients. The goal is to find out how effective and safe this medication is for weight loss.

To be eligible for the trial, participants must be at least 18 years old, have a body mass index (BMI) of 30 or more, or a BMI of 27 or more with certain health issues like high blood pressure or diabetes. They should also have tried to lose weight through dieting before but were unsuccessful. Participants can expect regular check-ups and support during the study, and they will be monitored for their weight loss progress and any side effects. It’s important to note that those with certain medical histories, like pancreatitis or major psychiatric disorders, are not eligible to participate.

Gender

ALL

Eligibility 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.