A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes
Hoffmann-La Roche
Summary
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) * Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-…
Interventions
- Combination ProductPlacebo
Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
- Combination ProductEnicepatide
Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
Locations (36)
- Lakeview Clinical ResearchGuntersville, Alabama
- Arizona Clinical TrialsTucson, Arizona
- Orange County Research CenterLake Forest, California
- Ark Clinical ResearchLong Beach, California
- Catalina Research Institute, LLCMontclair, California
- Prospective Research Innovations Inc.Rancho Cucamonga, California