ObesityPhase 1NCT07184086
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
A Phase 1 study testing CagriSema (Cagrilintide B + semaglutide I) and Low Energy Diet in people with Obesity, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- CagriSema (Cagrilintide B + semaglutide I) and Low Energy Diet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Sep 2025to 9 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex assigned at birth).
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- History of diabetes mellitus of any type, other than gestational diabetes mellitus.
- Claustrophobia or severe discomfort of being confined in small rooms.
- Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.
- Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
- Treatment with metformin or other glucose-lowering agent(s) within 90 days before screening (V1), regardless of indication.
Show all 9Show fewer
- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening (Visit 1).
- Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening (Visit 1).
- Physical measurement exceeding the dimensions or load capacity of the magnetic resonance imaging (MRI)/dual-energy X-ray absorptiometry (DEXA) scanner.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, 70808-4124
Advent Health-Res Inst
Orlando, Florida, 32804
About this study
Official title: The Effect of Cagrilintide and Semaglutide Combination Treatment Compared to a Weight-loss Inducing Diet on Energy Metabolism in Persons Living With Obesity: an Open-label Randomised Study
In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.
- Conditions
- Obesity
- Being tested
- CagriSema (Cagrilintide B + semaglutide I), Low Energy Diet
- 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 + semaglutide I)Drug
Cagrilintide and semaglutide will be administered subcutaneously.
Low Energy DietBehavioural
Participants will receive dietary intervention as per diet intervention manual.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema (Cagrilintide + Semaglutide) / CagriSema | Experimental | Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks. Receives: Drug: CagriSema (Cagrilintide B + semaglutide I) |
| Low Energy Diet (LED) / CagriSema | Experimental | Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks. Receives: Drug: CagriSema (Cagrilintide B + semaglutide I); Behavioral: Low Energy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleeping metabolic rate (SMR)
Measured as kilojoules (kJ) per day.
Measured: Baseline (Week 0) to Week 20
Secondary outcomes (3)
Change in 24-hour energy expenditure
Measured as kJ per day.
Measured: Baseline (Week 0) to Week 20
Change in resting metabolic rate (RMR)
Measured as kJ per day.
Measured: Baseline (Week 0) to Week 20
Change in basal metabolic rate (BMR)
Measured as kJ per day.
Measured: Baseline (Week 0) to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start26 Sep 2025
- Primary completion12 Oct 2027 (estimated)
- Study completion9 Feb 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
- None (open label)
- Enrolment
- 80 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
- NCT07184086
- Sponsor's protocol ID
- NN9838-8215
- Other IDs
- U1111-1316-8299
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2025
- Last updated
- 10 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cagrilintide and Semaglutide Combination Treatment Compared to a Weight-loss Inducing Diet on Energy Metabolism in Persons Living With Obesity: an Open-label Randomised Study
- ClinicalTrials.gov ID
- NCT07184086
- Acronym / sponsor ID
- NN9838-8215
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 12 Oct 2027 (estimated)
- Study completion
- 9 Feb 2028 (estimated)
- First posted
- 19 Sep 2025 (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.
In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CagriSema (Cagrilintide + Semaglutide) / CagriSema | Experimental | Drug: CagriSema (Cagrilintide B + semaglutide I)Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks. |
| Low Energy Diet (LED) / CagriSema | Experimental | Drug: CagriSema (Cagrilintide B + semaglutide I), Behavioral: Low Energy DietParticipants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female (sex assigned at birth).
- Age 18-65 years (both inclusive) at the time of signing the informed consent.
- Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (9 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- History of diabetes mellitus of any type, other than gestational diabetes mellitus.
- Claustrophobia or severe discomfort of being confined in small rooms.
- Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.
- Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
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 + semaglutide I)Cagrilintide and semaglutide will be administered subcutaneously. | Drug | CagriSema (Cagrilintide + Semaglutide) / CagriSema, Low Energy Diet (LED) / CagriSema |
| Low Energy DietParticipants will receive dietary intervention as per diet intervention manual. | Behavioural | Low Energy Diet (LED) / CagriSema |
Primary outcome
Change in sleeping metabolic rate (SMR)
Time frame: Baseline (Week 0) to Week 20
Measured as kilojoules (kJ) per day.
3 secondary outcomes
Change in 24-hour energy expenditure
Time frame: Baseline (Week 0) to Week 20
Change in resting metabolic rate (RMR)
Time frame: Baseline (Week 0) to Week 20
Change in basal metabolic rate (BMR)
Time frame: Baseline (Week 0) to Week 20
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
2 sites 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 + semaglutide I) and Low Energy Diet in people with Obesity, run by Novo Nordisk A/S at 2 sites 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 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 2 sites 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?
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?
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?
Change in sleeping metabolic rate (SMR) (time frame: Baseline (Week 0) to Week 20). 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 10 Sep 2026.