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Recruiting Phase 3 NCT07351045

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

Phase 3 – large-scale trial before approval
Conditions: Obesity or Overweight

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Placebo
COMBINATION_PRODUCT
Enicepatide
COMBINATION_PRODUCT
Locations 28
Argentina (1)
CINME
Buenos Aires
Australia (1)
Paratus Clinical Western Sydney
Blacktown , New South Wales
Canada (2)
Aggarwal and Associates
Brampton , Ontario
Wharton Medical Clinic
Hamilton , Ontario
Japan (4)
Kasugai Municipal Hospital
Aichi
NTT Medical Center Sapporo
Hokkaido
Hasegawa Medicine Clinic
Hokkaido
Higashijujo Sakai Diabetes Internal Medicine Clinic
Tokyo
Taiwan (8)
Changhua Christian Hospital
Changhua
Chia-Yi Christian Hospital
Chiayi City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chung Shan Medical University Hospital
Taichung
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
United States (12)
Pinnacle Research Group
Anniston , Alabama
Elevate Clinical Research
Gurnee , Illinois
Elevate Clinical
Houston , Texas
Monroe Biomedical Research
Louisville , Kentucky
Elevate Clinical
McAllen , Texas
International Diabetes Center At Park Nicollet
Minneapolis , Minnesota
Trial Management Associates
Myrtle Beach , South Carolina
Clinical Research Associates
Nashville , Tennessee
Headlands Reseach- Summit
Portland , Oregon
Artemis Institute for Clinical Research, LLC
San Diego , California
Clinvest Research LLC
Springfield , Missouri
Arizona Clinical Trials
Tucson , Arizona
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.03.2026
Completion date
28.08.2028
Registry ID
NCT07351045
Source
clinicaltrials.gov
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