A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Part of paid clinical trials in Northridge, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT06323161
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Key Dates

Start date
Mar 26, 2024
Status verified
Nov 2025
Primary completion
Sep 9, 2025
Completion
Oct 23, 2025

Study Design

Enrollment
274 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CagriSema Dose 1
    Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
  • Active Comparator: CagriSema Dose 2
    Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
  • Placebo Comparator: Placebo Dose 1
    Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.
  • Placebo Comparator: Placebo Dose 2
    Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks

Primary Outcome Measure

Change in Glycated Haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 40) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
Bioclinical Research AllianceMiamiFlorida33155-
Solaris Clinical ResearchMeridianIdaho83646-
Iowa Diab & Endo Res CenterWest Des MoinesIowa50266-
Alliance for Multispec ResNewtonKansas67114-
Elite Research CenterFlintMichigan48532-
Palm Research Center Inc.Las VegasNevada89128-
University of North CarolinaChapel HillNorth Carolina27614-
Clinical Research AssociatesNashvilleTennessee37203-
Velocity Clinical Res-DallasDallasTexas75230-
PlanIt Research, PLLCHoustonTexas77079-
Synergy Groups MedicalHoustonTexas77061-
Manassas Clinical Research CenterManassasVirginia20110-
TPMG Clinical ResearchNewport NewsVirginia23606-

Related coverage on Hipa.ai

Find similar trials in Northridge, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Valley Clinical Trials, Inc.· Northridge, CABioclinical Research Alliance· Miami, FLSolaris Clinical Research· Meridian, IDIowa Diab & Endo Res Center· West Des Moines, IAAlliance for Multispec Res· Newton, KSElite Research Center· Flint, MI

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