OverweightPhase 1NCT07605052
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
A Phase 1 study testing Cagrilintide B and Cagrilintide D in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Cagrilintide B and Cagrilintide D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 19 Aug 2026
- 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
- Age 18-64 years (both inclusive) at the time of signing informed consent.
- Male or female (sex assigned at birth).
- Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (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 (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Who cannot join
- Previous dosing of marketed or non-marketed amylin-agonists (a).
- Any condition, unwillingness or inability which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol (a).
- As declared by the participant, reported in the medical records or at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacokinetics of Two Different Presentations of Cagrilintide in Participants With Overweight and Obesity
The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Participant will be in this clinical study for about 14 weeks.
- Conditions
- Overweight, Obesity
- Being tested
- Cagrilintide B, Cagrilintide D
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cagrilintide BDrug
Cagrilintide B will be administered subcutaneously.
Cagrilintide DDrug
Cagrilintide D will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide B | Experimental | Participants will receive cagrilintide B subcutaneously once weekly for 5 weeks. Receives: Drug: Cagrilintide B |
| Cagrilintide D | Experimental | Participants will receive cagrilintide D subcutaneously once weekly for 5 weeks. Receives: Drug: Cagrilintide D |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide
Measured as hour*nanomole per liter (h*nmol/L).
Measured: From Pre-dose at Day 29 to Day 36
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide
Measured as nanomole per liter (nmol/L).
Measured: From Pre-dose at Day 29 to Day 36
Secondary outcomes (4)
AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide
Measured as h*nmol/L.
Measured: From Pre-dose at Day 22 to Day 29
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide
Measured as nmol/L.
Measured: From Pre-dose at Day 22 to Day 29
AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide
Measured as h*nmol/L.
Measured: From Pre-dose at Day 1 to Day 8
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 1st dosing of cagrilintide
Measured as nmol/L.
Measured: From Pre-dose at Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start20 May 2026
- Primary completion19 Aug 2026
- Study completion19 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07605052
- Sponsor's protocol ID
- NN9833-8819
- Other IDs
- U1111-1336-5994
- Status last verified
- Sep 2026
- First submitted
- 17 May 2026
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics of Two Different Presentations of Cagrilintide in Participants With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07605052
- Acronym / sponsor ID
- NN9833-8819
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- 19 Aug 2026 (actual)
- Study completion
- 19 Aug 2026 (actual)
- First posted
- 22 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.
The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Participant will be in this clinical study for about 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cagrilintide B | Experimental | Drug: Cagrilintide BParticipants will receive cagrilintide B subcutaneously once weekly for 5 weeks. |
| Cagrilintide D | Experimental | Drug: Cagrilintide DParticipants will receive cagrilintide D subcutaneously once weekly for 5 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-64 years (both inclusive) at the time of signing informed consent.
- Male or female (sex assigned at birth).
- Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (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 (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Key exclusion criteria (3 listed)
- Previous dosing of marketed or non-marketed amylin-agonists (a).
- Any condition, unwillingness or inability which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol (a).
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 BCagrilintide B will be administered subcutaneously. | Drug | Cagrilintide B |
| Cagrilintide DCagrilintide D will be administered subcutaneously. | Drug | Cagrilintide D |
Primary outcome
AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide
Time frame: From Pre-dose at Day 29 to Day 36
Measured as hour*nanomole per liter (h*nmol/L).
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide
Time frame: From Pre-dose at Day 29 to Day 36
Measured as nanomole per liter (nmol/L).
4 secondary outcomes
AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide
Time frame: From Pre-dose at Day 22 to Day 29
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide
Time frame: From Pre-dose at Day 22 to Day 29
AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide
Time frame: From Pre-dose at Day 1 to Day 8
Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 1st dosing of cagrilintide
Time frame: From Pre-dose at Day 1 to Day 8
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 4 Sep 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 Cagrilintide B and Cagrilintide D in people with Overweight and 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 4 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 4 Sep 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?
AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide (time frame: From Pre-dose at Day 29 to Day 36). 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 4 Sep 2026.