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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

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

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

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.