A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

Part of paid clinical trials in Orlando, Florida.

Sponsor
Novo Nordisk A/S
Study ID
NCT07184086
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • CagriSema (Cagrilintide B + semaglutide I) — DRUG
    Cagrilintide and semaglutide will be administered subcutaneously.
  • Low Energy Diet — BEHAVIORAL
    Participants will receive dietary intervention as per diet intervention manual.

Study Details

In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.

Key Dates

Start date
Sep 26, 2025
Status verified
Oct 2025
Primary completion
Oct 12, 2027
Completion
Oct 12, 2027

Study Design

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

Arms

  • Experimental: CagriSema (Cagrilintide + Semaglutide) / CagriSema
    Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.
  • Experimental: Low Energy Diet (LED) / CagriSema
    Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.

Primary Outcome Measure

Change in sleeping metabolic rate (SMR) [ Time Frame: Baseline (Week 0) to Week 20 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Advent Health-Res InstOrlandoFlorida32804-
Pennington Biomed Res CtrBaton RougeLouisiana70808-4124-

Find similar trials in Orlando, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Advent Health-Res Inst· Orlando, FLPennington Biomed Res Ctr· Baton Rouge, LA

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