OverweightPhase 1NCT07557953
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
A Phase 1 study testing Cagrilintide in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2026to 13 Apr 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
- Male or female (sex at birth).
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy, except for overweight or obesity, 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.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening.
- History of type 1 or type 2 diabetes mellitus
- Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
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- Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
- Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
- Previous dosing of marketed or non-marketed amylin-based compounds.
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: A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
- Conditions
- Overweight, Obesity
- Being tested
- Cagrilintide, Placebo Cagrilintide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Cagrilintide is administered subcutaneously .
Placebo CagrilintideDrug
Placebo Cagrilintide is administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide | Experimental | Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks. Receives: Drug: Cagrilintide |
| Placebo Cagrilintide | Placebo comparator | Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks. Receives: Drug: Placebo Cagrilintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Measured in percentage (%).
Measured: From baseline (Day 2) to end of treatment (Day 127)
Secondary outcomes (9)
Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Measured in kilojoule (kJ).
Measured: From baseline (Day 2) to end of treatment (Day 127)
Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box
Measured in grams (g).
Measured: From baseline (Day 2) to end of treatment (Day 127)
Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box
Measured in kJ.
Measured: From baseline (Day 2) to end of treatment (Day 127)
Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)
Measured in millimetre(mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4. Scores of 0 mm are worst and scores of 100 mm are best.
Measured: From baseline (Day 1) to end of treatment (Day 126)
Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption
Measured in mm. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4. Scores of 0 mm are worst and scores of 100 mm are best.
Measured: From baseline (Day 1) to end of treatment (Day 126)
Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness
Measured in mm. VAS appeal questions record the participant's sensations within taste, visual appearance and overall pleasantness by the participants on a paper printed scale line from 0 to 100 mm. Scores of 0 mm are worst and scores of 100 mm are best.
Measured: From baseline (Day 1) to end of treatment (Day 126)
Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS
Measured in mm. VAS appetite questions record the participant's sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4. Scores of 0 mm are worst and scores of 100 mm are best.
Measured: From baseline (Day 1) to end of treatment (Day 126)
• Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score
Measured in score points. The COEQ is a self-reported measure assessing various aspects of eating behaviour and related psychological factors. The COEQ has 19 different questions designed to assess the intensity and type of food cravings, as well as subjective sensations of appetite and mood. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control (0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); Higher score represents a greater level of Craving Control.
Measured: From baseline (Day -1) to end of treatment (Day 125)
Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score
Measured in score points. The power of food questionnaire measures three factors that correspond to different levels of food proximity and reflect responsiveness to food-abundant environments: food available (food that is available, but not physically present), food present (food that is present, but not tasted), and food tasted (food that is tasted, but not consumed). Moreover, an aggregate score is calculated as the mean of the three subdomains. The questionnaire consists of 15 questions, and the participants will be asked to rate their agreement or disagreement with each statement on a 5-point scale (ranging from "strongly disagree" to "strongly agree").
Measured: From baseline (Day -1) to end of treatment (Day 125)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start30 Apr 2026
- Primary completion13 Apr 2027 (estimated)
- Study completion13 Apr 2027 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- NCT07557953
- Sponsor's protocol ID
- NN9833-8421
- Other IDs
- U1111-1325-8810, 2025-524206-15, 2025
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 15 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07557953
- Acronym / sponsor ID
- NN9833-8421
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 13 Apr 2027 (estimated)
- Study completion
- 13 Apr 2027 (estimated)
- First posted
- 30 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 study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cagrilintide | Experimental | Drug: CagrilintideParticipant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks. |
| Placebo Cagrilintide | Placebo comparator | Drug: Placebo CagrilintideParticipant will receive placebo matched to Cagrilintide 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 (4 listed)
- Male or female (sex at birth).
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy, except for overweight or obesity, 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 (9 listed)
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening.
- History of type 1 or type 2 diabetes mellitus
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 |
|---|---|---|
| CagrilintideCagrilintide is administered subcutaneously . | Drug | Cagrilintide |
| Placebo CagrilintidePlacebo Cagrilintide is administered subcutaneously. | Drug | Placebo Cagrilintide |
Primary outcome
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Time frame: From baseline (Day 2) to end of treatment (Day 127)
Measured in percentage (%).
9 secondary outcomes
Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Time frame: From baseline (Day 2) to end of treatment (Day 127)
Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box
Time frame: From baseline (Day 2) to end of treatment (Day 127)
Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box
Time frame: From baseline (Day 2) to end of treatment (Day 127)
Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)
Time frame: From baseline (Day 1) to end of treatment (Day 126)
Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption
Time frame: From baseline (Day 1) to end of treatment (Day 126)
Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness
Time frame: From baseline (Day 1) to end of treatment (Day 126)
Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS
Time frame: From baseline (Day 1) to end of treatment (Day 126)
• Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score
Time frame: From baseline (Day -1) to end of treatment (Day 125)
Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score
Time frame: From baseline (Day -1) to end of treatment (Day 125)
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 15 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 in people with Overweight and Obesity, 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 4 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: looking for participants now, as of the sponsor's last update on 15 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 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. 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?
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box (time frame: From baseline (Day 2) to end of treatment (Day 127)). 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 15 May 2026.