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

RecruitingPhase 3

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 2,000 · Started: Mar 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07351045

Locations in the U.S.

AlabamaPinnacle Research Group, Anniston
Alabama Clinical Therapeutics, Birmingham
University of Alabama at Birmingham, Birmingham
ArizonaArizona Clinical Trials, Tucson
CaliforniaUniversity of California Irvine, Irvine
Artemis Institute for Clinical Research, LLC, San Diego
Diablo Clinical Research, Inc., Walnut Creek
ConnecticutYale University, New Haven
GeorgiaRophe Adult and Pediatric Medicine/SKYCRNG, Union City
HawaiiEast-West Medical Research Institute, Honolulu
IllinoisElevate Clinical Research, Gurnee
Knownwell, Schaumburg
Endeavor Health, Skokie
KentuckyMonroe Biomedical Research, Louisville
LouisianaAscension DePaul Health, New Orleans
MarylandBaltimore VA Medical Center, Baltimore
Johns Hopkins University School of Nursing, Baltimore
MassachusettsBoston Medical Center, Boston
Knownwell, Needham
MinnesotaInternational Diabetes Center At Park Nicollet, Minneapolis
MississippiDelRicht Research at Gulfport Memorial, Gulfport
MissouriClinvest Research LLC, Springfield
New YorkRochester Clinical Research, Buffalo
OhioHometown Urgent Care and Research - Dayton, Dayton
OklahomaDelricht Research of Tulsa Clinical Trials, Tulsa
OregonHeadlands Reseach- Summit, Portland
PennsylvaniaSuburban Research Associates - West Chester Office, West Chester
South CarolinaTrial Management Associates, Myrtle Beach
South DakotaCircle Clinical Research, Sioux Falls
TennesseeInnovative Clinical Research, Clarksville
Clinical Research Associates, Nashville
TexasBellaire Clinical Research, LLC, Bellaire
South Texas Research Institute - Brownsville, Brownsville
South Texas Clinical Research, Corpus Christi
University of Texas Southwestern Medical Center - Children's Medical Center Dallas, Dallas
Elevate Clinical, Houston
Houston Research Institute, Houston
Elevate Clinical, McAllen
IMA Clinical Research - San Antonio, San Antonio
Pinnacle Clinical Research - South San Antonio, San Antonio
Consano Clinical Research, Shavano Park
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance, Southlake
UtahGeorge E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City
WisconsinAscension Columbia St. Mary's, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.