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Clinical Trials in the UK / NCT07351045
Recruiting Phase 3

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

NCT07351045 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2026-03-16
Last updated
2026-09-14

Condition(s) studied

Obesity or Overweight

Investigational drug(s) / intervention(s)

PlaceboEnicepatide

Placebo: Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.

Enicepatide: Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.

Study 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

Sex
ALL
Min age
18 Years
Max age
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) Exclusion Criteria: * History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since. * 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) * History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening. * Poorly controlled hypertension at screening * 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. * Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication. * 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

Primary outcome measure(s)

Trial sites (203)

FacilityCityRegionStatus
Pinnacle Research Group Anniston Alabama Recruiting
Alabama Clinical Therapeutics Birmingham Alabama Recruiting
University of Alabama at Birmingham Birmingham Alabama Recruiting
Arizona Clinical Trials Tucson Arizona Recruiting
University of California Irvine Irvine California Recruiting
Artemis Institute for Clinical Research, LLC San Diego California Recruiting
Diablo Clinical Research, Inc. Walnut Creek California Recruiting
Yale University New Haven Connecticut Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia Recruiting
East-West Medical Research Institute Honolulu Hawaii Recruiting
Elevate Clinical Research Gurnee Illinois Recruiting
Knownwell Schaumburg Illinois Recruiting
Endeavor Health Skokie Illinois Recruiting
Monroe Biomedical Research Louisville Kentucky Recruiting
Ascension DePaul Health New Orleans Louisiana Recruiting
Baltimore VA Medical Center Baltimore Maryland Recruiting
Johns Hopkins University School of Nursing Baltimore Maryland Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Knownwell Needham Massachusetts Recruiting
International Diabetes Center At Park Nicollet Minneapolis Minnesota Recruiting
DelRicht Research at Gulfport Memorial Gulfport Mississippi Recruiting
Clinvest Research LLC Springfield Missouri Recruiting
Rochester Clinical Research Buffalo New York Recruiting
Hometown Urgent Care and Research - Dayton Dayton Ohio Recruiting
Delricht Research of Tulsa Clinical Trials Tulsa Oklahoma Recruiting
Headlands Reseach- Summit Portland Oregon Recruiting
Suburban Research Associates - West Chester Office West Chester Pennsylvania Recruiting
Trial Management Associates Myrtle Beach South Carolina Recruiting
Circle Clinical Research Sioux Falls South Dakota Recruiting
Innovative Clinical Research Clarksville Tennessee Recruiting
Clinical Research Associates Nashville Tennessee Recruiting
Bellaire Clinical Research, LLC Bellaire Texas Recruiting
South Texas Research Institute - Brownsville Brownsville Texas Recruiting
South Texas Clinical Research Corpus Christi Texas Recruiting
University of Texas Southwestern Medical Center - Children's Medical Center Dallas Dallas Texas Recruiting
Elevate Clinical Houston Texas Recruiting
Houston Research Institute Houston Texas Recruiting
Elevate Clinical McAllen Texas Recruiting
Pinnacle Clinical Research - South San Antonio San Antonio Texas Recruiting
IMA Clinical Research - San Antonio San Antonio Texas Recruiting

+ 163 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07351045 on ClinicalTrials.gov ↗ ← All trials in the UK