ObesityPhase 1RASMUSNCT07527195
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
A Phase 1 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Cagrilintide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2026to 9 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Age 50-70 years (both inclusive) at the time of signing the informed consent.
- Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening (V1).
- Excess body weight should be due to excess adipose tissue, as judged by the investigator.
- Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment.
Who cannot join
- Any leg amputations.
- Female participants who are not postmenopausal at screening.
- Any clinically significant body weight change (greater than or equal to [>=] 5% self-reported change) or dieting attempts within 90 days before screening.
- Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist or a medication with GLP-1 activity within 90 days before screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, 8200
About this study
Official title: Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function
The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 months.
- Conditions
- Obesity
- Being tested
- Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Participants will receive cagrilintide subcutaneously.
SemaglutideDrug
Participants will receive semaglutide subcutaneously.
Placebo cagrilintideDrug
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutideDrug
Participants will receive placebo matched to semaglutide subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema | Experimental | Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| Semaglutide | Experimental | Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks. Receives: Drug: Semaglutide; Drug: Placebo semaglutide |
| Cagrilintide | Experimental | Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks. Receives: Drug: Cagrilintide; Drug: Placebo cagrilintide |
| Placebo | Placebo comparator | Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks. Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
Measured in micromoles per 100 grams per minute (μmol/100g/min).
Measured: Baseline to Week 51
Secondary outcomes (2)
Change in insulin-stimulated FDG uptake in skeletal muscle
Measured in μmol/100g/min.
Measured: Baseline to Week 20
Change in insulin-stimulated FDG uptake in skeletal muscle
Measured in μmol/100g/min.
Measured: Baseline to Week 51
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start10 Apr 2026
- Primary completion28 Apr 2028 (estimated)
- Study completion9 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527195
- Sponsor's protocol ID
- NN9838-8411
- Other IDs
- U1111-1321-8655, 2025-522920-28, 2025
- Acronym
- RASMUS
- Status last verified
- May 2026
- First submitted
- 7 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function
- ClinicalTrials.gov ID
- NCT07527195
- Acronym / sponsor ID
- RASMUS / NN9838-8411
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 9 Jun 2028 (estimated)
- First posted
- 14 Apr 2026 (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.
The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CagriSema | Experimental | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks. |
| Semaglutide | Experimental | Drug: Semaglutide, Drug: Placebo semaglutideParticipants will receive once weekly s.c. dose of semaglutide for up to 52 weeks. |
| Cagrilintide | Experimental | Drug: Cagrilintide, Drug: Placebo cagrilintideParticipants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks. |
| Placebo | Placebo comparator | Drug: Placebo cagrilintide, Drug: Placebo semaglutideParticipants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female.
- Age 50-70 years (both inclusive) at the time of signing the informed consent.
- Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening (V1).
- Excess body weight should be due to excess adipose tissue, as judged by the investigator.
- Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment.
Key exclusion criteria (4 listed)
- Any leg amputations.
- Female participants who are not postmenopausal at screening.
- Any clinically significant body weight change (greater than or equal to [>=] 5% self-reported change) or dieting attempts within 90 days before screening.
- Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist or a medication with GLP-1 activity within 90 days before screening.
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 |
|---|---|---|
| CagrilintideParticipants will receive cagrilintide subcutaneously. | Drug | CagriSema, Cagrilintide |
| SemaglutideParticipants will receive semaglutide subcutaneously. | Drug | CagriSema, Semaglutide |
| Placebo cagrilintideParticipants will receive placebo matched to cagrilintide subcutaneously. | Drug | Cagrilintide, Placebo |
| Placebo semaglutideParticipants will receive placebo matched to semaglutide subcutaneously. | Drug | Placebo, Semaglutide |
Primary outcome
Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
Time frame: Baseline to Week 51
Measured in micromoles per 100 grams per minute (μmol/100g/min).
2 secondary outcomes
Change in insulin-stimulated FDG uptake in skeletal muscle
Time frame: Baseline to Week 20
Change in insulin-stimulated FDG uptake in skeletal muscle
Time frame: Baseline to Week 51
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- 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.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in Denmark.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle (time frame: Baseline to Week 51). 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 7 May 2026.