Recruiting

Phase 3

RO7795068A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes

Sponsor:

Hoffmann-La Roche

Code:

NCT07351045

Conditions

Obesity or Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Placebo

Enicepatide

Study Details

Brief 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.

Conditions

Obesity or Overweight

Study ID

NCT07351045

Start date

Mar 16, 2026

Status verified date

Aug, 2026

Completion date

Aug 28, 2028

Anticipated

Primary completion date

Jul 24, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Arm 1: Placebo

experimental: Arm 2: Enicepatide Dosing Regimen 1

experimental: Arm 3: Enicepatide Dosing Regimen 2

experimental: Arm 4: Enicepatide Dosing Regimen 3

Interventions

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.

Primary outcome measure

Percent (%) Change from Baseline in Body Weight at Week 72 [ Time Frame: Baseline through Week 72 ]

Central Contacts and Locations

Central contacts

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

Locations

Pinnacle Research Group

Recruiting

Anniston, Alabama, United States, 36207

Alabama Clinical Therapeutics

Recruiting

Birmingham, Alabama, United States, 35235

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-3360

Arizona Clinical Trials

Recruiting

Tucson, Arizona, United States, 85711

Artemis Institute for Clinical Research, LLC

Recruiting

San Diego, California, United States, 92123

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

Elevate Clinical Research

Recruiting

Gurnee, Illinois, United States, 60031

Knownwell

Recruiting

Schaumburg, Illinois, United States, 60194

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Monroe Biomedical Research

Recruiting

Louisville, Kentucky, United States, 40213

Ascension DePaul Health

Recruiting

New Orleans, Louisiana, United States, 70127

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Knownwell

Recruiting

Needham, Massachusetts, United States, 02492

International Diabetes Center At Park Nicollet

Recruiting

Minneapolis, Minnesota, United States, 55416

DelRicht Research at Gulfport Memorial

Recruiting

Gulfport, Mississippi, United States, 39503

Clinvest Research LLC

Recruiting

Springfield, Missouri, United States, 65807

Rochester Clinical Research

Recruiting

Buffalo, New York, United States, 14217

Hometown Urgent Care and Research - Dayton

Recruiting

Dayton, Ohio, United States, 45424

Delricht Research of Tulsa Clinical Trials

Recruiting

Tulsa, Oklahoma, United States, 74133

Headlands Reseach- Summit

Recruiting

Portland, Oregon, United States, 97210

Suburban Research Associates - West Chester Office

Recruiting

West Chester, Pennsylvania, United States, 19380

Trial Management Associates

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Circle Clinical Research

Recruiting

Sioux Falls, South Dakota, United States, 57104

Innovative Clinical Research

Recruiting

Clarksville, Tennessee, United States, 37040

Clinical Research Associates

Recruiting

Nashville, Tennessee, United States, 37203

Bellaire Clinical Research, LLC

Recruiting

Bellaire, Texas, United States, 77401

South Texas Research Institute - Brownsville

Recruiting

Brownsville, Texas, United States, 78520

South Texas Clinical Research

Recruiting

Corpus Christi, Texas, United States, 78404

University of Texas Southwestern Medical Center - Children's Medical Center Dallas

Recruiting

Dallas, Texas, United States, 75390

Elevate Clinical

Recruiting

Houston, Texas, United States, 77058

Houston Research Institute

Recruiting

Houston, Texas, United States, 77079

Elevate Clinical

Recruiting

McAllen, Texas, United States, 78504

Pinnacle Clinical Research - South San Antonio

Recruiting

San Antonio, Texas, United States, 78222

IMA Clinical Research - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Consano Clinical Research

Recruiting

Shavano Park, Texas, United States, 78231

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance

Recruiting

Southlake, Texas, United States, 76092

George E. Wahlen Department of Veterans Affairs Medical Center

Recruiting

Salt Lake City, Utah, United States, 841480001

Ascension Columbia St. Mary's

Recruiting

Milwaukee, Wisconsin, United States, 53211

C-health Partners Inc

Recruiting

Calgary, Alberta, Canada, T2V 4J2

Unity Healthcare Clinic

Recruiting

Surrey, British Columbia, Canada, V3T 4G8

Aggarwal and Associates

Recruiting

Brampton, Ontario, Canada, L6T 0G1

Hamilton Medical Research Group

Recruiting

Hamilton, Ontario, Canada, L8L 5G4

Wharton Medical Clinic

Recruiting

Hamilton, Ontario, Canada, L8L 5G8

Bluewater Clinical Research Group

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Diex Recherche Trois-Rivieres

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

Alpha Recherche Clinique

Recruiting

Québec, Canada, G2J0C4

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-14.