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

Conditions

Eligibility

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

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

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

Lakeview Clinical Research
Guntersville, Alabama 35976

Arizona Clinical Trials
Tucson, Arizona 85711

Orange County Research Center
Lake Forest, California 92630

Ark Clinical Research
Long Beach, California 90815

Catalina Research Institute, LLC
Montclair, California 91763

Prospective Research Innovations Inc.
Rancho Cucamonga, California 91730

Encompass Clinical Research
Spring Valley, California 91978

Emerson Clinical Research Institute
Washington D.C., District of Columbia 20009

Tampa Bay Medical Research, Inc.
Clearwater, Florida 33761

Center for Diabetes, Obesity and Metabolism Inc
Pembroke Pines, Florida 33024

Progressive Medical Research
Port Orange, Florida 32127

Eirvera, LLC
St. Petersburg, Florida 33711

Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia 31904

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

Elevate Clinical Research
Lake Charles, Louisiana 70605

Centennial Medical Group
Columbia, Maryland 21045-5840

Centricity Research Morehead City Multispeciality
Morehead City, North Carolina 28557

Remington Davis Inc
Columbus, Ohio 43215

Essential Medical Research
Tulsa, Oklahoma 74137

Coastal Carolina Research Center
North Charleston, South Carolina 29405

Circle Clinical Research
Sioux Falls, South Dakota 57104

Velocity Clinical Research
Dallas, Texas 75230

Juno Research, LLC
Houston, Texas 77040

HRI ? Pasadena, LLC
Pasadena, Texas 77505

DM Clinical Research
Tomball, Texas 77375

Manassas Clinical Research Center
Manassas, Virginia 20110

Centricity Research Suffolk Primary Care
Suffolk, Virginia 23435

Era Health Research
Redmond, Washington 98052

FDI Clinical Research
San Juan, Puerto Rico 00927

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WC45726 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.