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A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and 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 and Type 2 Diabetes

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
* Body mass index (BMI) ≥27.0 kg/m\^2
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
* 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)
* Poorly controlled hypertension at screening
* Have 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
* 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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

What is being tested

Sponsor: Hoffmann-La Roche · Participants: 1,600 · Started: Mar 23, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07351058

Locations in the U.S.

AlabamaLakeview Clinical Research, Guntersville
ArizonaArizona Clinical Trials, Tucson
CaliforniaOrange County Research Center, Lake Forest
Ark Clinical Research, Long Beach
Catalina Research Institute, LLC, Montclair
Infinity Clinical Research, Norco
Prospective Research Innovations Inc., Rancho Cucamonga
Encompass Clinical Research, Spring Valley
District of ColumbiaEmerson Clinical Research Institute, Washington D.C.
FloridaTampa Bay Medical Research, Inc., Clearwater
Center for Diabetes, Obesity and Metabolism Inc, Pembroke Pines
Progressive Medical Research, Port Orange
Eirvera, LLC, St. Petersburg
GeorgiaCentricity Research Columbus Georgia Multispecialty, Columbus
Rophe Adult and Pediatric Medicine/SKYCRNG, Union City
IdahoElite Clinical Trials, Blackfoot
LouisianaElevate Clinical Research, Lake Charles
Nola Care Clinical Research Center, Metairie
DelRicht Clinical Research, LLC, New Orleans
MarylandCentennial Medical Group, Columbia
MississippiOlive Branch Family Medical Center, Olive Branch
MissouriKansas City VA Medical Center, Kansas City
North CarolinaCentricity Research Morehead City Multispeciality, Morehead City
Wake Forest University Health Sciences, Winston-Salem
OhioRemington Davis Inc, Columbus
OklahomaLynn Institute of Norman, Norman
Lynn Health Science Institute, Oklahoma City
Essential Medical Research, Tulsa
PennsylvaniaVA Pittsburgh Healthcare System, Pittsburgh
South CarolinaCoastal Carolina Research Center, North Charleston
South DakotaCircle Clinical Research, Sioux Falls
TexasHeadlands Research Brownsville, Brownsville
Velocity Clinical Research, Dallas
South Texas Research Institute - Edinburg, Edinburg
HRI ? Medical Center, LLC, Houston
Juno Research, LLC, Houston
HRI ? Pasadena, LLC, Pasadena
Pinnacle Clinical Research - San Antonio, San Antonio
DM Clinical Research, Tomball
VirginiaManassas Clinical Research Center, Manassas
Centricity Research Suffolk Primary Care, Suffolk
WashingtonEra Health Research, Redmond

Conditions

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