A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

Sponsor
Hoffmann-La Roche
Study ID
NCT07670416
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enicepatide — COMBINATION_PRODUCT
    Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
  • Placebo — COMBINATION_PRODUCT
    Participants will receive matching placebo via SC injection as per the schedule in the protocol.

Study Details

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) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Key Dates

First listed
Jun 26, 2026
Start date
Jul 3, 2026
Status verified
Jul 2026
Primary completion
Feb 24, 2028
Completion
Mar 15, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enicepatide Dose 1
    Participants will receive enicepatide Dose 1.
  • Experimental: Enicepatide Dose 2
    Participants will receive enicepatide Dose 2.
  • Experimental: Enicepatide Dose 3
    Participants will receive enicepatide Dose 3.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo.

Primary Outcome Measure

Percent Change From Baseline in Body Weight at Week 52 [ Time Frame: Baseline through Week 52 ]

Central Contacts

  • Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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