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

Purpose

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.

Condition

  • Obesity or Overweight

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1: Placebo
  • Combination Product: Placebo
    Placebo will be volume-matched and administered once weekly using an integrated drug-device combination product.
Experimental
Arm 2: Enicepatide Dosing Regimen 1
  • Combination Product: Enicepatide
    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
    Other names:
    • RO7795068
    • CT-388
    • RG6640
Experimental
Arm 3: Enicepatide Dosing Regimen 2
  • Combination Product: Enicepatide
    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
    Other names:
    • RO7795068
    • CT-388
    • RG6640
Experimental
Arm 4: Enicepatide Dosing Regimen 3
  • Combination Product: Enicepatide
    Enicepatide will be administered once weekly at the randomized dosing regimen using an integrated drug-device combination product.
    Other names:
    • RO7795068
    • CT-388
    • RG6640

Recruiting Locations

Pinnacle Research Group
Anniston, Alabama 36207

Alabama Clinical Therapeutics
Birmingham, Alabama 35235

University of Alabama at Birmingham
Birmingham, Alabama 35294-3360

Arizona Clinical Trials
Tucson, Arizona 85711

Artemis Institute for Clinical Research, LLC
San Diego, California 92123

Yale University
New Haven, Connecticut 06519

Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291

East-West Medical Research Institute
Honolulu, Hawaii 96814

Elevate Clinical Research
Gurnee, Illinois 60031

Knownwell
Schaumburg, Illinois 60194

Endeavor Health
Skokie, Illinois 60077

Monroe Biomedical Research
Louisville, Kentucky 40213

Ascension DePaul Health
New Orleans, Louisiana 70127

Knownwell
Needham, Massachusetts 02492

International Diabetes Center At Park Nicollet
Minneapolis, Minnesota 55416

DelRicht Research at Gulfport Memorial
Gulfport, Mississippi 39503

Clinvest Research LLC
Springfield, Missouri 65807

Rochester Clinical Research
Buffalo, New York 14217

Hometown Urgent Care and Research - Dayton
Dayton, Ohio 45424

Delricht Research of Tulsa Clinical Trials
Tulsa, Oklahoma 74133

Headlands Reseach- Summit
Portland, Oregon 97210

Suburban Research Associates - West Chester Office
West Chester, Pennsylvania 19380

Trial Management Associates
Myrtle Beach, South Carolina 29572

Circle Clinical Research
Sioux Falls, South Dakota 57104

Innovative Clinical Research
Clarksville, Tennessee 37040

Clinical Research Associates
Nashville, Tennessee 37203

Bellaire Clinical Research, LLC
Bellaire, Texas 77401

South Texas Research Institute - Brownsville
Brownsville, Texas 78520

South Texas Clinical Research
Corpus Christi, Texas 78404

University of Texas Southwestern Medical Center - Children's Medical Center Dallas
Dallas, Texas 75390

Elevate Clinical
Houston, Texas 77058

Houston Research Institute
Houston, Texas 77079

Elevate Clinical
McAllen, Texas 78504

Pinnacle Clinical Research - South San Antonio
San Antonio, Texas 78222

IMA Clinical Research - San Antonio
San Antonio, Texas 78229

Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Southlake, Texas 76092

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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