ObesityPhase 1NCT07597018
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
A Phase 1 study testing Cagrilintide D in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Cagrilintide D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteGermany
- Study dates
- 18 May 2026to 1 Jun 2027
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Parexel International GmbH
Berlin, 14050
About this study
Official title: Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity
This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.
- Conditions
- Obesity, Overweight
- Being tested
- Cagrilintide D, Cagrilintide B and placebo semaglutide I
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cagrilintide DDrug
Cagrilintide D will be administered subcutaneously.
Cagrilintide B and placebo semaglutide IDrug
Cagrilintide B and placebo semaglutide I will be administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide B and Placebo Semaglutide I | Experimental | Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks. Receives: Drug: Cagrilintide B and placebo semaglutide I |
| Cagrilintide D-Injection site 1 | Experimental | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. Receives: Drug: Cagrilintide D |
| Cagrilintide D-Injection site 2 | Experimental | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. Receives: Drug: Cagrilintide D |
| Cagrilintide D-Injection site 3 | Experimental | Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. Receives: Drug: Cagrilintide D |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
Measured in hour nanomoles per litre (h*nmol/L)
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Measured in nanomoles per litre (nmol/L).
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
Secondary outcomes (13)
tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Measured in hours.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Measured in hours.
Measured: Day 113 (pre-dose) to Day 162 (post-dose)
Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.
Measured in litre.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.
Measured in litre per hours.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.
Measured in hours*nmol/L.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Measured in nmol/L.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Measured in hours.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c.
Measured in hours.
Measured: Day 113 (pre-dose) to Day 120 (post-dose)
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c
Measured in hours*nmol/L.
Measured: Day 22 (pre-dose) to Day 29 (post-dose)
Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Measured in nmol/L.
Measured: Day 22 (pre-dose) to Day 29 (post-dose)
tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Measured in hours.
Measured: Day 22 (pre-dose) to Day 29 (post-dose)
Number of treatment-emergent adverse events (TEAEs)
Measured in count of events.
Measured: Day 1 (randomisation) to Day 162 (end of study)
Number of treatment-emergent serious adverse events (TESAEs)
Measured in count of events.
Measured: Day 1 (randomisation) to Day 162 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start18 May 2026
- Primary completion28 May 2027 (estimated)
- Study completion1 Jun 2027 (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
- None (open label)
- Enrolment
- 234 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
- NCT07597018
- Sponsor's protocol ID
- NN9833-8285
- Other IDs
- U1111-1314-9337, 2025-521384-12, 2025
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 26 Jun 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07597018
- Acronym / sponsor ID
- NN9833-8285
- Conditions
- Obesity, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 May 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.
This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cagrilintide B and Placebo Semaglutide I | Experimental | Drug: Cagrilintide B and placebo semaglutide IParticipants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks. |
| Cagrilintide D-Injection site 1 | Experimental | Drug: Cagrilintide DParticipants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
| Cagrilintide D-Injection site 2 | Experimental | Drug: Cagrilintide DParticipants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
| Cagrilintide D-Injection site 3 | Experimental | Drug: Cagrilintide DParticipants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (2 listed)
- Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.
- Any condition which in the investigator's opinion might jeopardise participant'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 |
|---|---|---|
| Cagrilintide DCagrilintide D will be administered subcutaneously. | Drug | Cagrilintide D-Injection site 1, Cagrilintide D-Injection site 2, Cagrilintide D-Injection site 3 |
| Cagrilintide B and placebo semaglutide ICagrilintide B and placebo semaglutide I will be administered subcutaneously | Drug | Cagrilintide B and Placebo Semaglutide I |
Primary outcome
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in hour nanomoles per litre (h*nmol/L)
Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
Measured in nanomoles per litre (nmol/L).
13 secondary outcomes
tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 162 (post-dose)
Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c.
Time frame: Day 113 (pre-dose) to Day 120 (post-dose)
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c
Time frame: Day 22 (pre-dose) to Day 29 (post-dose)
Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Time frame: Day 22 (pre-dose) to Day 29 (post-dose)
tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.
Time frame: Day 22 (pre-dose) to Day 29 (post-dose)
Number of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 (randomisation) to Day 162 (end of study)
Number of treatment-emergent serious adverse events (TESAEs)
Time frame: Day 1 (randomisation) to Day 162 (end of study)
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 26 Jun 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 D in people with Obesity and Overweight, run by Novo Nordisk A/S at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 26 Jun 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 Germany. 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?
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?
AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c. (time frame: Day 113 (pre-dose) to Day 120 (post-dose)). The study lists 2 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 26 Jun 2026.