A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Part of paid clinical trials in Concord, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT05394519
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cagrilintide — DRUG
    Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
  • Semaglutide — DRUG
    Semaglutide administered subcutaneously (s.c., under the skin) once-weekly
  • Placebo cagrilintide — DRUG
    Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
  • Placebo semaglutide — DRUG
    Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Study Details

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Key Dates

Start date
Feb 1, 2023
Status verified
Jan 2026
Primary completion
Jan 28, 2025
Completion
Feb 3, 2025

Study Design

Enrollment
1,200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CagriSema
    Cagrilintide + semaglutide once weekly
  • Placebo Comparator: Placebo
    Placebo cagrilintide + semaglutide once weekly

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]

Locations (49)

FacilityCityStateZIPSite coordinators
John Muir Physicians NetworkConcordCalifornia94520-
Headlands Research California, LLCEscondidoCalifornia92025-
Providence Medical FoundationFullertonCalifornia92835-
St. Jos Heritage Hlthcr_FllrtnFullertonCalifornia92835-
Diabetes/Lipid Mgmt & Res CtrHuntington BeachCalifornia92648-
Clinical Trials ResearchLincolnCalifornia95648-
Velocity Clin Res Los AngelesLos AngelesCalifornia90017-
Velocity Clin Res WstlkeLos AngelesCalifornia90057-
Desert Oasis Hlthcr Med GroupPalm SpringsCalifornia92262-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
New West Physicians,Inc.GoldenColorado80401-
Clinical Res Of W Florida IncClearwaterFlorida33765-
Northeast Research InstituteFleming IslandFlorida32003-
Jacksonville Ctr For Clin ResJacksonvilleFlorida32216-
Renstar Medical ResearchOcalaFlorida34470-
AdventHealth Diab InstOrlandoFlorida32804-
Florida Institute for Clinical Research, LLCOrlandoFlorida32825-
Oviedo Medical Research, LLCOviedoFlorida32765-
Endo Res Solutions IncRoswellGeorgia30076-
East West Med Res InstHonoluluHawaii96814-
Cedar-Crosse Research CenterChicagoIllinois60607-
Iowa Diab & Endo Res CenterWest Des MoinesIowa50266-
Cotton-Oneill Diabetes and EndTopekaKansas66606-2806-
L-MARC Research CenterLouisvilleKentucky40213-
Pennington Biom Res CtrBaton RougeLouisiana70808-
Northern Pines Hlth Ctr, PCBuckleyMichigan49620-
International Diabetes CenterMinneapolisMinnesota55416-
StudyMetrix Research LLCCity of Saint PetersMissouri63303-
Mercury Str Med Grp, PLLCButteMontana59701-
AMC Community EndocrinologyAlbanyNew York12203-
Southgate Medical Group, LLPWest SenecaNew York14224-
Great Lakes Medical ResearchWestfieldNew York14787-
PharmQuest Life Sciences LLCGreensboroNorth Carolina27408-
Hillcrest Clinical ResearchSimpsonvilleSouth Carolina29681-1538-
Holston Medical GroupKingsportTennessee37660-
Amarillo Med Spec LLPAmarilloTexas79106-
Texas Diab & Endo, P.A.AustinTexas78731-
Texas Diab & Endo, P.A.AustinTexas78749-
North Texas Endocrine CenterDallasTexas75231-
UT Southwestern Med CntrDallasTexas75390-9302-
Velocity Clinical Res-DallasDallasTexas75230-
PlanIt Research, PLLCHoustonTexas77079-
DCOL Ctr for Clin ResLongviewTexas75605-
Consano Clinical Research, LLCShavano ParkTexas78231-
Chrysalis Clinical ResearchSt. GeorgeUtah84790-
National Clin Res Inc.RichmondVirginia23294-
Amherst Family Practice P.C.WinchesterVirginia22601-
Selma Medical AssociatesWinchesterVirginia22601-3834-
Capital Clin Res Ctr,LLCOlympiaWashington98502-

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