Recruiting
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
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).
ClinicalTrials.gov IDNCT07351058
PhasePHASE3
Enrollment1600
SponsorHoffmann-La Roche
Age18 Years
SexALL
Conditions studied
Obesity or Overweight, Type 2 Diabetes Mellitus
About this study
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).
Interventions
- Combination Product: Placebo — Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
- Combination Product: Enicepatide — Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
Primary outcomes
- Percent (%) Change from Baseline in Body Weight at Week 72 (Baseline through Week 72)
Eligibility information
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-4) inhibitors or GLP-1 RA-based therapy.
* Body mass index (BMI) ≥27.0 kg/m\^2
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion Criteria:
* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* Poorly controlled hypertension at screening
* Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
Study locations
- Lakeview Clinical Research, Guntersville, Alabama 35976 United States
- Arizona Clinical Trials, Tucson, Arizona 85711 United States
- Orange County Research Center, Lake Forest, California 92630 United States
- Ark Clinical Research, Long Beach, California 90815 United States
- Catalina Research Institute, LLC, Montclair, California 91763 United States
- Infinity Clinical Research, Norco, California 92860 United States
- Prospective Research Innovations Inc., Rancho Cucamonga, California 91730 United States
- Encompass Clinical Research, Spring Valley, California 91978 United States
- Emerson Clinical Research Institute, Washington D.C., District of Columbia 20009 United States
- Tampa Bay Medical Research, Inc., Clearwater, Florida 33761 United States
Showing 10 of 204 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.