Diabetes Mellitus, Type 2Phase 2NCT04982575
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
A Phase 2 study testing Semaglutide 2.4 mg and Cagrilintide 2.4 mg in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide 2.4 mg and Cagrilintide 2.4 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 23 sitesUnited States
- Study dates
- 2 Aug 2021to 7 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Ellipsis Group
Alpharetta, Georgia, 30022
Uni of Alabama at Birmingham
Birmingham, Alabama, 35233
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
Lillestol Research LLC
Fargo, North Dakota, 58104
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, 58104
Valley Research
Fresno, California, 93720
Macoupin Research Group
Gillespie, Illinois, 62033
New West Physicians,Inc.
Golden, Colorado, 80401
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
East West Med Res Inst
Honolulu, Hawaii, 96814
PlanIt Research, PLLC
Houston, Texas, 77079
Holston Medical Group
Kingsport, Tennessee, 37660
FPA Clinical Research
Kissimmee, Florida, 34741
DCOL Ctr for Clin Res
Longview, Texas, 75605
Pacific Clinical Studies
Los Alamitos, California, 90720
Velocity Clin Res Los Angeles
Los Angeles, California, 90017
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502
Florida Inst For Clin Res
Orlando, Florida, 32825
MD Medical Research
Oxon Hill, Maryland, 20745
Clinical Trial Res Assoc,Inc
Plantation, Florida, 33324
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601-3834
About this study
Official title: Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes
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.
Read more
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
- Being tested
- Semaglutide 2.4 mg, Cagrilintide 2.4 mg, Placebo (semaglutide), Placebo (cagrilintide)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 2.4 mgDrug
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 mgDrug
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)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
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
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide 2.4 mg and semaglutide 2.4 mg | Experimental | Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks. Receives: 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 Receives: 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 Receives: Drug: Semaglutide 2.4 mg; Drug: Placebo (cagrilintide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Week 0, Week 32
Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Percenatge change in body weight 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.
Measured: Week 0, Week 32
Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Change in body weight 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.
Measured: 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)
Change in FPG 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.
Measured: Week 0, Week 32
CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Change in mean glucose from baslline (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.
Measured: Week 0, Week 32
Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Percentage of TAR greater than 10.0 mmol/L (greater than 180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range greater than 10.0 mmol/L (greater than 180 mg/dL), both inclusive divided by the total number of recorded measurements. 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.
Measured: At week 32
Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Percentage of TIR 3.9-10.0 mmol/L (70-180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. 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.
Measured: At week 32
Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participants administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.
Measured: From baseline (week 0) to week 37
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 37 are presented. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.
Measured: From baseline (week 0) to week 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start2 Aug 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982575
- Sponsor's protocol ID
- NN9838-4862
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2021
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 37364590
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04982575
- Acronym / sponsor ID
- NN9838-4862
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cagrilintide 2.4 mg and semaglutide 2.4 mg | Experimental | Drug: Semaglutide 2.4 mg, Drug: Cagrilintide 2.4 mgParticipants will receive cagrilintide and semaglutide once a week as injections for 32 weeks. |
| Cagrilintide 2.4 mg and placebo (semaglutide) | Active comparator | Drug: Cagrilintide 2.4 mg, Drug: Placebo (semaglutide)Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks |
| Semaglutide 2.4 mg and Placebo (cagrilintide) | Active comparator | Drug: Semaglutide 2.4 mg, Drug: Placebo (cagrilintide)Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 2.4 mgSemaglutide 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 | Drug | Cagrilintide 2.4 mg and semaglutide 2.4 mg, Semaglutide 2.4 mg and Placebo (cagrilintide) |
| Cagrilintide 2.4 mgCagrilintide 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 | Drug | Cagrilintide 2.4 mg and placebo (semaglutide), Cagrilintide 2.4 mg and semaglutide 2.4 mg |
| 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 | Drug | Cagrilintide 2.4 mg and placebo (semaglutide) |
| 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 | Drug | Semaglutide 2.4 mg and Placebo (cagrilintide) |
Primary outcome
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Time frame: Week 0, Week 32
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.
9 secondary outcomes
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Time frame: Week 0, Week 32
Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Time frame: Week 0, Week 32
Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Time frame: 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)
Time frame: Week 0, Week 32
CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Time frame: Week 0, Week 32
Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Time frame: At week 32
Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
Time frame: At week 32
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to week 37
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
Time frame: From baseline (week 0) to week 37
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37364590Frias 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 1452) study director
Novo Nordisk A/S
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide 2.4 mg and Cagrilintide 2.4 mg in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) (time frame: Week 0, Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.