Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
NCT ID: NCT04982575
Last Updated: 2025-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2021-08-02
2022-07-07
Brief Summary
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Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.
Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.
A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.
Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.
The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.
At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).
Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cagrilintide 2.4 mg and semaglutide 2.4 mg
Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.
Semaglutide 2.4 mg
Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Cagrilintide 2.4 mg
Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Cagrilintide 2.4 mg and placebo (semaglutide)
Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks
Cagrilintide 2.4 mg
Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Placebo (semaglutide)
Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Semaglutide 2.4 mg and Placebo (cagrilintide)
Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks
Semaglutide 2.4 mg
Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Placebo (cagrilintide)
Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Interventions
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Semaglutide 2.4 mg
Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Cagrilintide 2.4 mg
Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Placebo (semaglutide)
Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Placebo (cagrilintide)
Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Eligibility Criteria
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Inclusion Criteria
* Age above or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 27.0 kg/m\^2
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening
* Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m\^2 by central laboratory at screening
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Uni of Alabama at Birmingham
Birmingham, Alabama, United States
Valley Research
Fresno, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, United States
New West Physicians,Inc.
Golden, Colorado, United States
FPA Clinical Research
Kissimmee, Florida, United States
Florida Inst For Clin Res
Orlando, Florida, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
Ellipsis Group
Alpharetta, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Macoupin Research Group
Gillespie, Illinois, United States
MD Medical Research
Oxon Hill, Maryland, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, United States
Holston Medical Group
Kingsport, Tennessee, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Selma Medical Associates
Winchester, Virginia, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
Countries
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References
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Frias JP, Deenadayalan S, Erichsen L, Knop FK, Lingvay I, Macura S, Mathieu C, Pedersen SD, Davies M. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023 Aug 26;402(10403):720-730. doi: 10.1016/S0140-6736(23)01163-7. Epub 2023 Jun 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NN9838-4862
Identifier Type: -
Identifier Source: org_study_id