A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
Amgen
Summary
The primary objective of this study is to determine the effect of maridebart cafraglutide relative to placebo on insulin sensitivity in participants with Type 2 Diabetes Mellitus (T2DM) treated with stable dose of metformin.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Informed consent before initiation of any study-specific activities/procedures. * Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent. * Body mass index 27 ≥ and ≤ 45 kg/m\^2 at screening. * Diagnosis of T2DM at least 6 months before screening based on the WHO classification. * Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin. Exclusion Criteria: *…
Interventions
- DrugMaridebart cafraglutide
Maridebart cafraglutide will be administered SC.
- DrugPlacebo
Placebo will be administered SC.
Location
- ProSciento, Inc. - Main ClinicChula Vista, California