A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

Part of paid clinical trials in Covina, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT06780449
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cagrilintide — DRUG
    Participants will receive cagrilintide subcutaneously.
  • Semaglutide — DRUG
    Participants will receive semaglutide subcutaneously.
  • Placebo cagrilintide — DRUG
    Participants will receive placebo matched to cagrilintide subcutaneously.
  • Placebo semaglutide — DRUG
    Participants will receive placebo matched to semaglutide subcutaneously.

Study Details

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Key Dates

Start date
Feb 10, 2025
Status verified
Jan 2026
Primary completion
Aug 28, 2028
Completion
Oct 31, 2028

Study Design

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

Arms

  • Experimental: CagriSema
    Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to week 104 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Valley Clinical TrialsCovinaCalifornia91723-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Yale University School Of MedicineNew HavenConnecticut06519-
East West Medical Research Institute_HonoluluHonoluluHawaii96814-
L-MARC Research CenterLouisvilleKentucky40213-
StudyMetrix Research LLCCity of Saint PetersMissouri63303-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
Holston Medical Group_BristolBristolTennessee37620-
North Texas Endocrine CenterDallasTexas75231-
Washington Cntr Weight MgmtArlingtonVirginia22206-

Find similar trials in Covina, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Valley Clinical Trials· Covina, CADiablo Clinical Research, Inc.· Walnut Creek, CAYale University School Of Medicine· New Haven, CTEast West Medical Research Institute_Honolulu· Honolulu, HIL-MARC Research Center· Louisville, KYStudyMetrix Research LLC· City of Saint Peters, MO

Related Studies