Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

Part of paid clinical trials in Walnut Creek, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT07607587
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Cagrilintide — DRUG
    Cagrilintide will be administered subcutaneously.
  • Placebo (matched to Cagrilintide) — DRUG
    Placebo matched to Cagrilintide will be administered subcutaneously.

Study Details

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Key Dates

Start date
May 29, 2026
Status verified
May 2026
Primary completion
Nov 19, 2027
Completion
Nov 19, 2027

Study Design

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

Arms

  • Experimental: Cagrilintide
    Participants will receive Cagrilintide for 26 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to Cagrilintide for 26 weeks.

Primary Outcome Measure

Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo [ Time Frame: At week 26 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Northeast Research InstituteFleming IslandFlorida32003-
Jacksonville Ctr For Clin ResJacksonvilleFlorida32216-
Center for Diab,Obes & MetabPembroke PinesFlorida33024-
Encore Medical Research of WestonWestonFlorida33331-
Monroe Biomedical Research, LLCMonroeNorth Carolina28112-
AccellacareWilmingtonNorth Carolina28401-
Coastal Carolina Research CtrNorth CharlestonSouth Carolina29405-
Holston Medical Group_BristolBristolTennessee37620-
Amarillo Medical SpecialistsAmarilloTexas79124-
Elligo Clin Res CentreAustinTexas78704-

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