A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obesity or Overweight, Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT07351058

Run by

Hoffmann-La Roche

People needed

1600

Starts

2026-03-23

Expected to finish

2028-08-07

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Clinical Trials — Tucson, Arizona, United States (enrolling)
• Orange County Research Center — Lake Forest, California, United States (enrolling)
• Ark Clinical Research — Long Beach, California, United States (enrolling)
• Catalina Research Institute, LLC — Montclair, California, United States (enrolling)
• Infinity Clinical Research — Norco, California, United States (enrolling)
• Prospective Research Innovations Inc. — Rancho Cucamonga, California, United States (enrolling)
• Encompass Clinical Research — Spring Valley, California, United States (enrolling)
• Emerson Clinical Research Institute — Washington D.C., District of Columbia, United States (enrolling)
• Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States (enrolling)
• Center for Diabetes, Obesity and Metabolism Inc — Pembroke Pines, Florida, United States (enrolling)
• Progressive Medical Research — Port Orange, Florida, United States (enrolling)
• Eirvera, LLC — St. Petersburg, Florida, United States (enrolling)
• Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia, United States (enrolling)
• Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia, United States (enrolling)
• Elevate Clinical Research — Lake Charles, Louisiana, United States (enrolling)
• DelRicht Clinical Research, LLC — New Orleans, Louisiana, United States (enrolling)
• Centennial Medical Group — Columbia, Maryland, United States (enrolling)
• Centricity Research Morehead City Multispeciality — Morehead City, North Carolina, United States (enrolling)
• Remington Davis Inc — Columbus, Ohio, United States (enrolling)
• Lynn Institute of Norman — Norman, Oklahoma, United States (enrolling)
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States (enrolling)
• Essential Medical Research — Tulsa, Oklahoma, United States (enrolling)
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States (enrolling)
• Coastal Carolina Research Center — North Charleston, South Carolina, United States (enrolling)
• Lakeview Clinical Research — Guntersville, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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