ObesityPhase 1NCT06207877
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
A Phase 1 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Cagrilintide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2024to 22 Nov 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Aged 18-65 years (both inclusive) at the time of signing informed consent.
- 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.
- Body mass index (BMI) equal to or above 27.0 kilograms per meter square (kg/m^2) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Who cannot join
- Glycated haemoglobin (HbA1C) greater than or equal to (≥) 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 attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Effect of Cagrilintide and Semaglutide Combination Treatment(CagriSema) on Energy Intake, Appetite and Gastric Emptying in People With Overweight or Obesity
This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.
- Conditions
- Obesity
- Being tested
- Cagrilintide, Semaglutide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Cagrilintide will be administered subcutaneously.
SemaglutideDrug
Semaglutide will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema | Experimental | Participants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| Placebo | Active comparator | Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in energy intake during ad libitum lunch, evening meal and snackbox
Measured in percentage (%).
Measured: Baseline to Day 156
Secondary outcomes (22)
Change in energy intake during ad libitum lunch, evening meal and snackbox
Measured in kilojoule (KJ).
Measured: Baseline to Day 156
Change in amount of food consumed during ad libitum lunch, evening meal and snackbox
Measured in grams (g).
Measured: Baseline to Day 156
AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal
Measured in hour*milligram per milliliter ( h*mg/mL).
Measured: Day 1 and Day 155: 0-5 hour after standardised meal
AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal
Measured in h*mg/mL.
Measured: Day 1 and Day 155: 0-1 hour after standardised meal
Cmax,para, maximum observed paracetamol concentration
Measured in microgram per milliliter (µcg/mL).
Measured: Day 1 and Day 155: 0-5 hour after standardised meal
tmax,para, time to maximum observed paracetamol concentration after start of standardised meal
Measured in hours (h).
Measured: Day 1 and Day 155: 0-5 hour after standardised meal
Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box
Measured in %-point.
Measured: Baseline to Day 156
Change in Control of Eating questionnaire (COEQ): Craving Control score
The Control of Eating Questionnaire (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: Baseline to Day 154
Change in COEQ: Positive Mood score
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: Baseline to Day 154
Change in COEQ: Craving for Sweets score
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: Baseline to Day 154
Change in COEQ: Craving for Savoury food score
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: Baseline to Day 154
Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger
Measured in millimeter (mm). VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness, 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: Baseline to Day 156
Change in mean postprandial VAS ratings of Fullness
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: Baseline to Day 156
Change in mean postprandial VAS ratings of Satiety
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: Baseline to Day 156
Change in mean postprandial VAS ratings of 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: Baseline to Day 156
Change in mean postprandial VAS ratings of Appetite Score
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: Baseline to Day 156
Change in Power of Food questionnaire for Food available score
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: Baseline to Day 155
Change in Power of Food questionnaire for Food present score
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: Baseline to Day 155
Change in Power of Food questionnaire for Food tasted score
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: Baseline to Day 155
Change in Power of Food questionnaire for Composite score
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: Baseline to Day 155
Change in mean score from the Monetary Choice Questionnaire
The 27-item version of the Monetary Choice Questionnaire63 is used to assess participants' individual preference for immediate versus delayed monetary rewards. The questions comprise hypothetical choices between smaller immediate rewards or larger delayed rewards. The specific amounts and delays of the rewards vary across questions. For each question, the participant is asked to choose which option they would prefer. The responses are used to calculate a measure of participants' willingness to delay gratification and their discount rate (k) for delayed rewards.
Measured: Baseline to Day 157
Change in body weight
Measured in %.
Measured: Baseline to Day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start23 Feb 2024
- Primary completion16 Oct 2024
- Study completion22 Nov 2024
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 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
- NCT06207877
- Sponsor's protocol ID
- NN9838-4695
- Other IDs
- U1111-1286-0585, 2023-504792-24-00, 2023
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2024
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effect of Cagrilintide and Semaglutide Combination Treatment(CagriSema) on Energy Intake, Appetite and Gastric Emptying in People With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06207877
- Acronym / sponsor ID
- NN9838-4695
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 17 Jan 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 research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 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 |
|---|---|---|
| CagriSema | Experimental | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks. |
| Placebo | Active comparator | Drug: PlaceboParticipants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female.
- Aged 18-65 years (both inclusive) at the time of signing informed consent.
- 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.
- Body mass index (BMI) equal to or above 27.0 kilograms per meter square (kg/m^2) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Key exclusion criteria (5 listed)
- Glycated haemoglobin (HbA1C) greater than or equal to (≥) 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 attempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
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 will be administered subcutaneously. | Drug | CagriSema |
| SemaglutideSemaglutide will be administered subcutaneously. | Drug | CagriSema |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
Relative change in energy intake during ad libitum lunch, evening meal and snackbox
Time frame: Baseline to Day 156
Measured in percentage (%).
22 secondary outcomes
Change in energy intake during ad libitum lunch, evening meal and snackbox
Time frame: Baseline to Day 156
Change in amount of food consumed during ad libitum lunch, evening meal and snackbox
Time frame: Baseline to Day 156
AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal
Time frame: Day 1 and Day 155: 0-5 hour after standardised meal
AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal
Time frame: Day 1 and Day 155: 0-1 hour after standardised meal
Cmax,para, maximum observed paracetamol concentration
Time frame: Day 1 and Day 155: 0-5 hour after standardised meal
tmax,para, time to maximum observed paracetamol concentration after start of standardised meal
Time frame: Day 1 and Day 155: 0-5 hour after standardised meal
Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box
Time frame: Baseline to Day 156
Change in Control of Eating questionnaire (COEQ): Craving Control score
Time frame: Baseline to Day 154
Change in COEQ: Positive Mood score
Time frame: Baseline to Day 154
Change in COEQ: Craving for Sweets score
Time frame: Baseline to Day 154
Change in COEQ: Craving for Savoury food score
Time frame: Baseline to Day 154
Change in mean postprandial Visual Analogue Scale (VAS) ratings of Hunger
Time frame: Baseline to Day 156
Change in mean postprandial VAS ratings of Fullness
Time frame: Baseline to Day 156
Change in mean postprandial VAS ratings of Satiety
Time frame: Baseline to Day 156
Change in mean postprandial VAS ratings of Prospective food consumption
Time frame: Baseline to Day 156
Change in mean postprandial VAS ratings of Appetite Score
Time frame: Baseline to Day 156
Change in Power of Food questionnaire for Food available score
Time frame: Baseline to Day 155
Change in Power of Food questionnaire for Food present score
Time frame: Baseline to Day 155
Change in Power of Food questionnaire for Food tasted score
Time frame: Baseline to Day 155
Change in Power of Food questionnaire for Composite score
Time frame: Baseline to Day 155
Change in mean score from the Monetary Choice Questionnaire
Time frame: Baseline to Day 157
Change in body weight
Time frame: Baseline to Day 155
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 8 Jan 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 and Semaglutide in people with 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 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 8 Jan 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?
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?
Relative change in energy intake during ad libitum lunch, evening meal and snackbox (time frame: Baseline to Day 156). 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 8 Jan 2026.