Obesity & OverweightPhase 1NCT04940078
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
A Phase 1 study testing Cagrilintide, semaglutide and Cagrilintide and semaglutide in people with Obesity & Overweight, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. The medicines will either be given together in 1 injection or as 2 separate injections. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Cagrilintide, semaglutide and Cagrilintide and semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Jul 2021to 16 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female of non-childbearing potential (NCBP)
- Aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
Who cannot join
- Previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. Participation is defined as randomisation
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Investigation of Pharmacokinetics Following Co-administration of Cagrilintide (NNC0174-0833) and Semaglutide Versus Separate Injections in Subjects With Overweight or Obesity
This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. The medicines will either be given together in 1 injection or as 2 separate injections.
The aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood.
Read more
For the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2 separate injections. Then participants will either switch to getting the medicines as a combined injection or continue to get the separate injections for 8 weeks. Which treatment participants get after the first 14 weeks is decided by chance.
Participants will get the study medicines once a week for 22 weeks. A study nurse at the clinic will inject the medicines with a thin needle in participants stomach area.
The study will last for about 8 months.Participants will have 28 clinic visits with the study staff. For 4 of these visits, participants will stay in the clinic for 5 nights.
Participants will have blood drawn at 21 visits. Participants will have clinical assessments and participants will be asked about their health, medical history and habits including mental health questionnaires.
For women: Participants must not be able to become pregnant if they wish to participate in this study.
- Conditions
- Obesity & Overweight
- Being tested
- Cagrilintide, semaglutide, Cagrilintide and semaglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks
semaglutideDrug
Once weekly doses of semaglutide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. over 2 weeks
Cagrilintide and semaglutideDrug
Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cagrilintide and semaglutide in separate syringes | Experimental | Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period. Receives: Drug: Cagrilintide; Drug: semaglutide |
| Part A: Cagrilintide and semaglutide combined in DV3384 device | Experimental | Participants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period. Receives: Drug: Cagrilintide and semaglutide |
| Part B: Cagrilintide and semaglutide combined in DV3384 device | Experimental | Participants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period. Receives: Drug: Cagrilintide and semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
measured in nmol⸱h/L
Measured: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
Cmax,cagri,2.4/2.4mg,SS maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
measured in nmol/L
Measured: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
AUC0-168h,sema,2.4/2.4mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
measured in nmol⸱h/L
Measured: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
Cmax,sema,2.4/2.4mg,SS maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
measured in nmol/L
Measured: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
Secondary outcomes (8)
tmax,cagri,2.4/2.4mg,SS time since last dosing to maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
measured in hours
Measured: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
t½,cagri,2.4/2.4mg,SS terminal half-life of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
measured in hours
Measured: Day 148 (pre-dose) to Day 186 (912 hours post-dose)
tmax,sema,2.4/2.4mg,SS time since last dosing to maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
measured in hours
Measured: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
t½,sema,2.4/2.4mg,SS terminal half-life of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
measured in hours
Measured: Day 148 (pre-dose) to Day 186 (912 hours post-dose)
AUC0-168h,cagri,1.7/1.7mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of cagrilintide 1.7 mg in combination with semaglutide 1.7 mg
measured in nmol⸱h/L
Measured: Day 120 (pre-dose) to Day 127 (168 hours post-dose)
AUC0-168h,sema,1.7/1.7mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of semaglutide 1.7 mg in combination with cagrilintide 1.7 mg
measured in nmol⸱h/L
Measured: Day 120 (pre-dose) to Day 127 (168 hours post-dose)
PART A: Number of treatment emergent adverse events
count
Measured: From time of dosing (Day 1) to follow-up (Day 186)
PART B: Number of treatment emergent adverse events
Count
Measured: From time of dosing (Day 1) to follow-up (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start7 Jul 2021
- Primary completion19 Jan 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial consists of a Part A with multiple weekly dosings at site and a Part B with a single dose (SD) part of the first dose step in Part A.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT04940078
- Sponsor's protocol ID
- NN9838-4614
- Other IDs
- U1111-1250-7789
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2021
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics Following Co-administration of Cagrilintide (NNC0174-0833) and Semaglutide Versus Separate Injections in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04940078
- Acronym / sponsor ID
- NN9838-4614
- Conditions
- Obesity & Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. The medicines will either be given together in 1 injection or as 2 separate injections.
The aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood.
For the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2 separate injections. Then participants will either switch to getting the medicines as a combined injection or continue to get the separate injections for 8 weeks. Which treatment participants get after the first 14 weeks is decided by chance.
Participants will get the study medicines once a week for 22 weeks. A study nurse at the clinic will inject the medicines with a thin needle in participants stomach area.
The study will last for about 8 months.Participants will have 28 clinic visits with the study staff. For 4 of these visits, participants will stay in the clinic for 5 nights.
Participants will have blood drawn at 21 visits. Participants will have clinical assessments and participants will be asked about their health, medical history and habits including mental health questionnaires.
For women: Participants must not be able to become pregnant if they wish to participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The trial consists of a Part A with multiple weekly dosings at site and a Part B with a single dose (SD) part of the first dose step in Part A.
| Arm | Type | Receives |
|---|---|---|
| Part A: Cagrilintide and semaglutide in separate syringes | Experimental | Drug: Cagrilintide, Drug: semaglutideParticipants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period. |
| Part A: Cagrilintide and semaglutide combined in DV3384 device | Experimental | Drug: Cagrilintide and semaglutideParticipants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period. |
| Part B: Cagrilintide and semaglutide combined in DV3384 device | Experimental | Drug: Cagrilintide and semaglutideParticipants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female of non-childbearing potential (NCBP)
- Aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
Key exclusion criteria (2 listed)
- Previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. Participation is defined as randomisation
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
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 |
|---|---|---|
| CagrilintideOnce weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks | Drug | Part A: Cagrilintide and semaglutide in separate syringes |
| semaglutideOnce weekly doses of semaglutide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. over 2 weeks | Drug | Part A: Cagrilintide and semaglutide in separate syringes |
| Cagrilintide and semaglutideCagrilintide and semaglutide combined and administered using the DV3384 manual syringe | Drug | Part A: Cagrilintide and semaglutide combined in DV3384 device, Part B: Cagrilintide and semaglutide combined in DV3384 device |
Primary outcome
AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
measured in nmol⸱h/L
Cmax,cagri,2.4/2.4mg,SS maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
measured in nmol/L
AUC0-168h,sema,2.4/2.4mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
measured in nmol⸱h/L
Cmax,sema,2.4/2.4mg,SS maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
measured in nmol/L
8 secondary outcomes
tmax,cagri,2.4/2.4mg,SS time since last dosing to maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
t½,cagri,2.4/2.4mg,SS terminal half-life of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 186 (912 hours post-dose)
tmax,sema,2.4/2.4mg,SS time since last dosing to maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)
t½,sema,2.4/2.4mg,SS terminal half-life of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg
Time frame: Day 148 (pre-dose) to Day 186 (912 hours post-dose)
AUC0-168h,cagri,1.7/1.7mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of cagrilintide 1.7 mg in combination with semaglutide 1.7 mg
Time frame: Day 120 (pre-dose) to Day 127 (168 hours post-dose)
AUC0-168h,sema,1.7/1.7mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of semaglutide 1.7 mg in combination with cagrilintide 1.7 mg
Time frame: Day 120 (pre-dose) to Day 127 (168 hours post-dose)
PART A: Number of treatment emergent adverse events
Time frame: From time of dosing (Day 1) to follow-up (Day 186)
PART B: Number of treatment emergent adverse events
Time frame: From time of dosing (Day 1) to follow-up (Day 29)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cagrilintide, semaglutide and Cagrilintide and semaglutide in people with Obesity & Overweight, run by Novo Nordisk A/S at 2 sites in 2 countries.
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 3 inclusion and 2 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 12 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 2 sites in Canada, Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg (time frame: Day 148 (pre-dose) to Day 155 (168 hours post-dose)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.