Recruiting
Phase 3

RO7795068

Sponsor:

Hoffmann-La Roche

Code:

NCT07351058

Conditions

Obesity or Overweight

Type 2 Diabetes Mellitus

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 with obesity or overweight and Type 2 diabetes mellitus (T2DM).

Conditions

Obesity or Overweight

Type 2 Diabetes Mellitus

Study ID

NCT07351058

Start date

Mar 23, 2026

Status verified date

Aug, 2026

Completion date

Aug 7, 2028

Anticipated

Primary completion date

Aug 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1600 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: WC45726 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Lakeview Clinical Research

Recruiting

Guntersville, Alabama, United States, 35976

Arizona Clinical Trials

Recruiting

Tucson, Arizona, United States, 85711

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Infinity Clinical Research

Recruiting

Norco, California, United States, 92860

Prospective Research Innovations Inc.

Recruiting

Rancho Cucamonga, California, United States, 91730

Encompass Clinical Research

Recruiting

Spring Valley, California, United States, 91978

Emerson Clinical Research Institute

Recruiting

Washington D.C., District of Columbia, United States, 20009

Tampa Bay Medical Research, Inc.

Recruiting

Clearwater, Florida, United States, 33761

Center for Diabetes, Obesity and Metabolism Inc

Recruiting

Pembroke Pines, Florida, United States, 33024

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Eirvera, LLC

Recruiting

St. Petersburg, Florida, United States, 33711

Centricity Research Columbus Georgia Multispecialty

Recruiting

Columbus, Georgia, United States, 31904

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

Elite Clinical Trials

Recruiting

Blackfoot, Idaho, United States, 83221

Elevate Clinical Research

Recruiting

Lake Charles, Louisiana, United States, 70605

DelRicht Clinical Research, LLC

Recruiting

New Orleans, Louisiana, United States, 70115

Centennial Medical Group

Recruiting

Columbia, Maryland, United States, 21045-5840

Centricity Research Morehead City Multispeciality

Recruiting

Morehead City, North Carolina, United States, 28557

Remington Davis Inc

Recruiting

Columbus, Ohio, United States, 43215

Lynn Institute of Norman

Recruiting

Norman, Oklahoma, United States, 73072

Lynn Health Science Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Essential Medical Research

Recruiting

Tulsa, Oklahoma, United States, 74137

VA Pittsburgh Healthcare System

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

Circle Clinical Research

Recruiting

Sioux Falls, South Dakota, United States, 57104

Headlands Research Brownsville

Recruiting

Brownsville, Texas, United States, 78526

Velocity Clinical Research

Recruiting

Dallas, Texas, United States, 75230

South Texas Research Institute - Edinburg

Recruiting

Edinburg, Texas, United States, 78539

HRI ? Medical Center, LLC

Recruiting

Houston, Texas, United States, 77004

Juno Research, LLC

Recruiting

Houston, Texas, United States, 77040

HRI ? Pasadena, LLC

Recruiting

Pasadena, Texas, United States, 77505

Pinnacle Clinical Research - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

DM Clinical Research

Recruiting

Tomball, Texas, United States, 77375

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

Centricity Research Suffolk Primary Care

Recruiting

Suffolk, Virginia, United States, 23435

Era Health Research

Recruiting

Redmond, Washington, United States, 98052

Centricity Research Calgary Endocrinology

Recruiting

Calgary, Alberta, Canada, T2H 2G4

TGElliott Inc. dba BC Diabetes

Recruiting

Vancouver, British Columbia, Canada, V5Y 3W2

Centricity Research Brampton Endocrinology

Recruiting

Brampton, Ontario, Canada, L6S 0C6

Medicor Research Inc

Recruiting

Greater Sudbury, Ontario, Canada, P3C 1X3

LMC Clinical Research Inc

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Applied Medical Informatics Research Inc. (A.M.I.R.)

Recruiting

Montreal, Quebec, Canada, H4A 3T2

Diex Recherche Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1L 0H8

Clinique des maladies lipidiques de Quebec

Recruiting

Québec, Canada, G1V 4W2

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 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-14.