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Clinical Trials in the UK / NCT07351058
Recruiting Phase 3

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

NCT07351058 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2026-03-23
Last updated
2026-09-14

Condition(s) studied

Obesity or OverweightType 2 Diabetes Mellitus

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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Eligibility

Sex
ALL
Min age
18 Years
Max age
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-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

Primary outcome measure(s)

Trial sites (204)

FacilityCityRegionStatus
Lakeview Clinical Research Guntersville Alabama Recruiting
Arizona Clinical Trials Tucson Arizona Recruiting
Orange County Research Center Lake Forest California Recruiting
Ark Clinical Research Long Beach California Recruiting
Catalina Research Institute, LLC Montclair California Recruiting
Infinity Clinical Research Norco California Recruiting
Prospective Research Innovations Inc. Rancho Cucamonga California Recruiting
Encompass Clinical Research Spring Valley California Recruiting
Emerson Clinical Research Institute Washington D.C. District of Columbia Recruiting
Tampa Bay Medical Research, Inc. Clearwater Florida Recruiting
Center for Diabetes, Obesity and Metabolism Inc Pembroke Pines Florida Recruiting
Progressive Medical Research Port Orange Florida Recruiting
Eirvera, LLC St. Petersburg Florida Recruiting
Centricity Research Columbus Georgia Multispecialty Columbus Georgia Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia Recruiting
Elite Clinical Trials Blackfoot Idaho Recruiting
Elevate Clinical Research Lake Charles Louisiana Recruiting
Nola Care Clinical Research Center Metairie Louisiana Recruiting
DelRicht Clinical Research, LLC New Orleans Louisiana Recruiting
Centennial Medical Group Columbia Maryland Recruiting
Olive Branch Family Medical Center Olive Branch Mississippi Recruiting
Kansas City VA Medical Center Kansas City Missouri Recruiting
Centricity Research Morehead City Multispeciality Morehead City North Carolina Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina Recruiting
Remington Davis Inc Columbus Ohio Recruiting
Lynn Institute of Norman Norman Oklahoma Recruiting
Lynn Health Science Institute Oklahoma City Oklahoma Recruiting
Essential Medical Research Tulsa Oklahoma Recruiting
VA Pittsburgh Healthcare System Pittsburgh Pennsylvania Recruiting
Coastal Carolina Research Center North Charleston South Carolina Recruiting
Circle Clinical Research Sioux Falls South Dakota Recruiting
Headlands Research Brownsville Brownsville Texas Recruiting
Velocity Clinical Research Dallas Texas Recruiting
South Texas Research Institute - Edinburg Edinburg Texas Recruiting
HRI ? Medical Center, LLC Houston Texas Recruiting
Juno Research, LLC Houston Texas Recruiting
HRI ? Pasadena, LLC Pasadena Texas Recruiting
Pinnacle Clinical Research - San Antonio San Antonio Texas Recruiting
DM Clinical Research Tomball Texas Recruiting
Manassas Clinical Research Center Manassas Virginia Recruiting

+ 164 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 NCT07351058 on ClinicalTrials.gov ↗ ← All trials in the UK