ObesityPhase 1NCT06716307
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
A Phase 1 study testing CagriSema (cagrilintide B and semaglutide I) and CagriSema A in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity
- What is being tested?
- CagriSema (cagrilintide B and semaglutide I) and CagriSema A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 28 Mar 2025
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous dosing with an amylin analogue.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Glycosylated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (48 millimoles per mole [mmol/mol]) at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Pharmacokinetics of Cagrilintide and Semaglutide Following Single Subcutaneous Doses of Different CagriSema Presentations, in a Crossover Manner in Adult Participants With Overweight or Obesity
This study will compare the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.
- Conditions
- Obesity
- Being tested
- CagriSema (cagrilintide B and semaglutide I), CagriSema A
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagriSema (cagrilintide B and semaglutide I)Drug
Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
CagriSema ADrug
Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Participants will receive a single subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 1 followed by a single s.c. dose of CagriSema A in PDS290 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. Receives: Drug: CagriSema (cagrilintide B and semaglutide I); Drug: CagriSema A |
| Treatment sequence 2 | Experimental | Participants will receive a single s.c. dose of CagriSema A in PDS290 pen-injector in period 1 followed by a single s.c. dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. Receives: Drug: CagriSema (cagrilintide B and semaglutide I); Drug: CagriSema A |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in hours*nanomoles per liter (h*nmol/L).
Measured: From 0 hours (pre-dose) to 1176 hours (post-dose)
Cmax,cagri,0.25mg/0.25mg,SD: Maximum concentration of cagrilintide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in nanomoles per liter (nmol/L).
Measured: From 0 hours (pre-dose) to 1176 hours (post-dose)
AUC0-∞,sema,0.25mg/0.25mg,SD: Area under the semaglutide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in h*nmol/L.
Measured: From 0 hours (pre-dose) to 1176 hours (post-dose)
Cmax,sema,0.25mg/0.25mg,SD: Maximum concentration of semaglutide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Measured in nmol/L.
Measured: From 0 hours (pre-dose) to 1176 hours (post-dose)
Secondary outcomes (1)
Number of adverse events
Measured as number of events.
Measured: From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start2 Dec 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
- NCT06716307
- Sponsor's protocol ID
- NN9838-8259
- Other IDs
- U1111-1309-7476
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2024
- Last updated
- 31 Aug 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Pharmacokinetics of Cagrilintide and Semaglutide Following Single Subcutaneous Doses of Different CagriSema Presentations, in a Crossover Manner in Adult Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06716307
- Acronym / sponsor ID
- NN9838-8259
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 4 Dec 2024 (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 the blood levels of cagrilintide and semaglutide when the same dose is given in two different versions of CagriSema. CagriSema is a medicine that combines two medicines called cagrilintide and semaglutide. It is still being tested in studies and is not yet available for doctors to prescribe. Participants will get an injection with each of the two versions of CagriSema at two different times at the clinic. Like all medicines, the study medicine may have side effects. The study will last for about 18 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: CagriSema (cagrilintide B and semaglutide I), Drug: CagriSema AParticipants will receive a single subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 1 followed by a single s.c. dose of CagriSema A in PDS290 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. |
| Treatment sequence 2 | Experimental | Drug: CagriSema (cagrilintide B and semaglutide I), Drug: CagriSema AParticipants will receive a single s.c. dose of CagriSema A in PDS290 pen-injector in period 1 followed by a single s.c. dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female.
- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) between 27.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (5 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous dosing with an amylin analogue.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Glycosylated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (48 millimoles per mole [mmol/mol]) at 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 |
|---|---|---|
| CagriSema (cagrilintide B and semaglutide I)Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector. | Drug | Treatment sequence 1, Treatment sequence 2 |
| CagriSema ACagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector. | Drug | Treatment sequence 1, Treatment sequence 2 |
Primary outcome
AUC0-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in hours*nanomoles per liter (h*nmol/L).
Cmax,cagri,0.25mg/0.25mg,SD: Maximum concentration of cagrilintide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in nanomoles per liter (nmol/L).
AUC0-∞,sema,0.25mg/0.25mg,SD: Area under the semaglutide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in h*nmol/L.
Cmax,sema,0.25mg/0.25mg,SD: Maximum concentration of semaglutide after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector
Time frame: From 0 hours (pre-dose) to 1176 hours (post-dose)
Measured in nmol/L.
1 secondary outcome
Number of adverse events
Time frame: From first investigational medicinal product (IMP) administration (Day 1) to the end of study visit (Day 99)
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 31 Aug 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. This study is not recruiting at the moment.
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 CagriSema (cagrilintide B and semaglutide I) and CagriSema A in people with Obesity, run by Novo Nordisk A/S at 1 site 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 5 inclusion and 5 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 31 Aug 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 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 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-∞,cagri,0.25 milligram (mg)/0.25mg,SD: Area under the cagrilintide concentration-time curve after a single dose 0.25 mg/0.25 mg CagriSema A in PDS290 pen-injector or CagriSema in DV3384 pen-injector (time frame: From 0 hours (pre-dose) to 1176 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 31 Aug 2026.