A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Hoffmann-La Roche · NCT07351045
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 2000
- US sites recruiting
- 44
- Study start
- March 16, 2026
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Placebo; Enicepatide
Conditions: Obesity or Overweight
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Pinnacle Research Group
Anniston, AL 36207
Alabama Clinical Therapeutics
Birmingham, AL 35235
University of Alabama at Birmingham
Birmingham, AL 35294-3360
Arizona Clinical Trials
Tucson, AZ 85711
University of California Irvine
Irvine, CA 92612
Artemis Institute for Clinical Research, LLC
San Diego, CA 92123
Diablo Clinical Research, Inc.
Walnut Creek, CA 94598
Yale University
New Haven, CT 06519
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, GA 30291
East-West Medical Research Institute
Honolulu, HI 96814
Elevate Clinical Research
Gurnee, IL 60031
Knownwell
Schaumburg, IL 60194
Endeavor Health
Skokie, IL 60077
Monroe Biomedical Research
Louisville, KY 40213
Ascension DePaul Health
New Orleans, LA 70127
Baltimore VA Medical Center
Baltimore, MD 21201
Johns Hopkins University School of Nursing
Baltimore, MD 21205
Boston Medical Center
Boston, MA 02118
Knownwell
Needham, MA 02492
International Diabetes Center At Park Nicollet
Minneapolis, MN 55416
DelRicht Research at Gulfport Memorial
Gulfport, MS 39503
Clinvest Research LLC
Springfield, MO 65807
Rochester Clinical Research
Buffalo, NY 14217
Hometown Urgent Care and Research - Dayton
Dayton, OH 45424
Delricht Research of Tulsa Clinical Trials
Tulsa, OK 74133
Headlands Reseach- Summit
Portland, OR 97210
Suburban Research Associates - West Chester Office
West Chester, PA 19380
Trial Management Associates
Myrtle Beach, SC 29572
Circle Clinical Research
Sioux Falls, SD 57104
Innovative Clinical Research
Clarksville, TN 37040
Clinical Research Associates
Nashville, TN 37203
Bellaire Clinical Research, LLC
Bellaire, TX 77401
South Texas Research Institute - Brownsville
Brownsville, TX 78520
South Texas Clinical Research
Corpus Christi, TX 78404
University of Texas Southwestern Medical Center - Children's Medical Center Dallas
Dallas, TX 75390
Elevate Clinical
Houston, TX 77058
Houston Research Institute
Houston, TX 77079
Elevate Clinical
McAllen, TX 78504
Pinnacle Clinical Research - South San Antonio
San Antonio, TX 78222
IMA Clinical Research - San Antonio
San Antonio, TX 78229
Consano Clinical Research
Shavano Park, TX 78231
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Southlake, TX 76092
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, UT 841480001
Ascension Columbia St. Mary's
Milwaukee, WI 53211
Study contacts (from the official record)
- Reference Study ID Number: WC45725 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. Only) · global-roche-genentech-trials@gene.com
- Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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