A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Established Cardiovascular Disease

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT07843472
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cardiovascular Disease
  • Obesity or Overweight

Eligibility Criteria

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

Interventions

  • Petrelintide — COMBINATION_PRODUCT
    Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.
  • Placebo — COMBINATION_PRODUCT
    Petrelintide-matching placebo will be administered SC using a drug-device combination product.

Study Details

This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD).

Key Dates

First listed
Sep 28, 2026
Start date
Sep 30, 2026
Status verified
Oct 2026
Primary completion
Jul 28, 2030
Completion
Oct 6, 2030

Study Design

Enrollment
2,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Petrelintide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage Change in Body Weight from Baseline [ Time Frame: From Baseline to Week 64 ]

Central Contacts

  • Reference Study ID Number: CC46446 https://forpatients.roche.com/No attachments to email below.
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (3)

FacilityCityStateZIPSite coordinators
Pinnacle Research GroupAnnistonAlabama36207-
Institute for Metabolic Research Los AngelesLos AngelesCalifornia90015-
Progressive Medical ResearchPort OrangeFlorida32127-

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By research site
Pinnacle Research Group· Anniston, ALInstitute for Metabolic Research Los Angeles· Los Angeles, CAProgressive Medical Research· Port Orange, FL

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