Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

NCT04982575 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NN9838-4862
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 23

Brief Summary

This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone. 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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

  Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications.

  Week 0, Week 32

Secondary Outcomes (9)

• Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

  Week 0, Week 32

• Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

  Week 0, Week 32

• Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

  Week 0, Week 32

• Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)

  Week 0, Week 32

• CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)

  Week 0, Week 32

Study Arms (3)

Cagrilintide 2.4 mg and semaglutide 2.4 mg

EXPERIMENTAL

Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.

Drug: Semaglutide 2.4 mg; Drug: Cagrilintide 2.4 mg

Cagrilintide 2.4 mg and placebo (semaglutide)

ACTIVE COMPARATOR

Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks

Drug: Cagrilintide 2.4 mg; Drug: Placebo (semaglutide)

Semaglutide 2.4 mg and Placebo (cagrilintide)

ACTIVE COMPARATOR

Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks

Drug: Semaglutide 2.4 mg; Drug: Placebo (cagrilintide)

Interventions

Semaglutide 2.4 mg DRUG

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 and semaglutide 2.4 mg; Semaglutide 2.4 mg and Placebo (cagrilintide)

Cagrilintide 2.4 mg DRUG

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); Cagrilintide 2.4 mg and semaglutide 2.4 mg

Placebo (semaglutide) DRUG

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

Cagrilintide 2.4 mg and placebo (semaglutide)

Placebo (cagrilintide) DRUG

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

Semaglutide 2.4 mg and Placebo (cagrilintide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female of non-childbearing potential or male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (23)

Uni of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

Location

New West Physicians,Inc.

Golden, Colorado, 80401, United States

Location

FPA Clinical Research

Kissimmee, Florida, 34741, United States

Location

Florida Inst For Clin Res

Orlando, Florida, 32825, United States

Location

Clinical Trial Res Assoc,Inc

Plantation, Florida, 33324, United States

Location

Ellipsis Group

Alpharetta, Georgia, 30022, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

Macoupin Research Group

Gillespie, Illinois, 62033, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Plains Clinical Research Center, LLC_Fargo

Fargo, North Dakota, 58104, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

Related Publications (1)

• 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.

  PMID: 37364590 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; cagrilintide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 29, 2021
• Study Start: August 2, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: December 23, 2025
• Results First Posted: July 27, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (23)