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 Without 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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or 2. BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight * Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations) Excl…
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 (28)
- Pinnacle Research GroupAnniston, Alabama
- Arizona Clinical TrialsTucson, Arizona
- Artemis Institute for Clinical Research, LLCSan Diego, California
- Elevate Clinical ResearchGurnee, Illinois
- Monroe Biomedical ResearchLouisville, Kentucky
- International Diabetes Center At Park NicolletMinneapolis, Minnesota