A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Recruiting · NCT07351045 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
EnicepatidePlacebo
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must have at screening:
- Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
- 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
Where it is running
60 locations listed across 25 US states.
- Pinnacle Research Group - Anniston, Alabama, United States
- Alabama Clinical Therapeutics - Birmingham, Alabama, United States
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Arizona Clinical Trials - Tucson, Arizona, United States
- University of California Irvine - Irvine, California, United States
- Artemis Institute for Clinical Research, LLC - San Diego, California, United States
- Diablo Clinical Research, Inc. - Walnut Creek, California, United States
- Yale University - New Haven, Connecticut, United States
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City, Georgia, United States
- East-West Medical Research Institute - Honolulu, Hawaii, United States
- Elevate Clinical Research - Gurnee, Illinois, United States
- Knownwell - Schaumburg, Illinois, United States
- Endeavor Health - Skokie, Illinois, United States
- Monroe Biomedical Research - Louisville, Kentucky, United States
- Ascension DePaul Health - New Orleans, Louisiana, United States
- Baltimore VA Medical Center - Baltimore, Maryland, United States
- Johns Hopkins University School of Nursing - Baltimore, Maryland, United States
- Boston Medical Center - Boston, Massachusetts, United States
- Knownwell - Needham, Massachusetts, United States
- International Diabetes Center At Park Nicollet - Minneapolis, Minnesota, United States
- DelRicht Research at Gulfport Memorial - Gulfport, Mississippi, United States
- Clinvest Research LLC - Springfield, Missouri, United States
- Rochester Clinical Research - Buffalo, New York, United States
- Hometown Urgent Care and Research - Dayton - Dayton, Ohio, United States
- Delricht Research of Tulsa Clinical Trials - Tulsa, Oklahoma, United States
- Headlands Reseach- Summit - Portland, Oregon, United States
- Suburban Research Associates - West Chester Office - West Chester, Pennsylvania, United States
- Trial Management Associates - Myrtle Beach, South Carolina, United States
- Circle Clinical Research - Sioux Falls, South Dakota, United States
- Innovative Clinical Research - Clarksville, Tennessee, United States
- Clinical Research Associates - Nashville, Tennessee, United States
- Bellaire Clinical Research, LLC - Bellaire, Texas, United States
- South Texas Research Institute - Brownsville - Brownsville, Texas, United States
- South Texas Clinical Research - Corpus Christi, Texas, United States
- University of Texas Southwestern Medical Center - Children's Medical Center Dallas - Dallas, Texas, United States
- Elevate Clinical - Houston, Texas, United States
- Houston Research Institute - Houston, Texas, United States
- Elevate Clinical - McAllen, Texas, United States
- Pinnacle Clinical Research - South San Antonio - San Antonio, Texas, United States
- IMA Clinical Research - San Antonio - San Antonio, Texas, United States
- Consano Clinical Research - Shavano Park, Texas, United States
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Southlake, Texas, United States
- George E. Wahlen Department of Veterans Affairs Medical Center - Salt Lake City, Utah, United States
- Ascension Columbia St. Mary's - Milwaukee, Wisconsin, United States
- AZORG Campus Aalst-Moorselbaan - Aalst, Belgium
- Kasugai Municipal Hospital - Aichi, Japan
- Monklands Hospital - Airdrie, United Kingdom
- Amsterdam UMC Location AMC - Amsterdam, Netherlands
- CHU d'Angers - Angers, France
- Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum Medizinische Fakultät OWL (Universität Bielefeld);Klinik für Diabetologie und Endokrinologie - Bad Oeynhausen, Germany
- DRC Gyogyszervizsgalo Kozpont Kft - Balatonfüred, Hungary
- Hospital del Mar - Barcelona, Spain
- Hospital Universitario Vall d Hebron - Barcelona, Spain
- Peking University People's Hospital - Beijing, China
- Beijing Pinggu Hospital - Beijing, China
- NZOZ Specialistyczny Osrodek Internistyczno - Diabetologiczny - Bialystok, Poland
- Birmingham Heartlands Hospital - Birmingham, United Kingdom
- CHU de Rouen - HOPITAL Bois Guillaume - Bois-Guillaume, France
- Hospital Erasme - Brussels, Belgium
- Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika - Budapest, Hungary
Showing 60 of 203 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →