Diabetes Mellitus, Type 2Phase 1NCT06403761
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
A Phase 1 study testing Semaglutide and Cagrilintide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide and Cagrilintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- 6 May 2024to 2 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Aged 18-75 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes greater than or equal to (>=) 180 days before screening.
- Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (<) 60 milliliter per minute per 1.73 square meter [ml/min/1.73 m^2]).
- Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole [mmol/mol]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c >= 7.0 % at screening.
- Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.
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.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m^2 at screening.
- Treatment with any medication for the indication of T2D or weight management other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CagriSema, Semaglutide and Cagrilintide on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes
This study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide, Cagrilintide, Placebo semaglutide, Placebo cagrilintide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive once-weekly semaglutide subcutaneously.
CagrilintideDrug
Participants will receive once-weekly cagrilintide subcutaneously.
Placebo semaglutideDrug
Participants will receive once-weekly placebo matched to semaglutide subcutaneously.
Placebo cagrilintideDrug
Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks. Receives: Drug: Semaglutide; Drug: Cagrilintide; Drug: Placebo semaglutide; Drug: Placebo cagrilintide |
| Semaglutide | Experimental | Participants will receive once-weekly s.c injections of semaglutide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks. Receives: Drug: Semaglutide; Drug: Placebo semaglutide |
| Cagrilintide | Experimental | Participants will receive once-weekly s.c injections of cagrilintide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks. Receives: Drug: Cagrilintide; Drug: Placebo cagrilintide |
| Placebo | Placebo comparator | Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 28 weeks. Receives: Drug: Placebo semaglutide; Drug: Placebo cagrilintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC)
M-value from the HEC is calculated from glucose infusion rate (GIR) over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight [milligram per minute per kilogram {mg/min/kg}]). Measured in mg/min/kg.
Measured: Baseline to week 28
Secondary outcomes (25)
To compare the effect of CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC
M-value from the HEC is calculated from GIR over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight [mg/min/kg]). Measured in mg/min/kg.
Measured: Baseline to week 28
To compare the effect of CagriSema versus placebo, CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC, normalised by lean body mass
M-value from the HEC is calculated from GIR over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight [mg/min/kg]). Measured in mg/min/kg.
Measured: Baseline to week 28
Change in first-phase incremental insulin secretion rate (ISR0-8min) in hyperglycaemic clamp (HGC)
Measured in picomoles per minute per square meter (pmol/min/m^2).
Measured: Baseline to week 28
Change in second-phase insulin secretion rate (ISR20-120min) in HGC
Measured in pmol/min/m^2.
Measured: Baseline to week 28
Change in total insulin secretion rate (ISR0-120min) in HGC
Measured in pmol/min/m^2.
Measured: Baseline to week 28
Change in insulin secretion rate at fixed glucose concentration (ISRg) in HGC
Measured in pmol/min/m^2.
Measured: Baseline to week 28
Change in total insulin response (total AUC0-120 min) in HGC
Measured in minute * picomoles per liter (min*pmol/L).
Measured: Baseline to week 28
Change in insulin response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Measured in min*pmol/L.
Measured: Baseline to week 28
Change in C-peptide response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Measured in min*nmol/L.
Measured: Baseline to week 28
Change in clamp disposition index (cDI) calculated from HEC and HGC
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Measured in picomoles * liter per square meter per square minute per kilogram (pmol*L/m^2/min^2/kg).
Measured: Baseline to week 28
Change in cDI calculated from HEC and HGC,based on lean body mass
cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Measured in pmol*L/m^2/min^2/kg.
Measured: Baseline to week 28
Change in β-cell glucose sensitivity (insulin secretion) from HGC
Measured in picomoles per minute per square meter per millimoles per liter (pmol/min/m^2/[mmol/L]).
Measured: Baseline to week 28
Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose)
Measured in pmol/min/m^2/(mmol/L).
Measured: Baseline to week 28
Change in glucose concentration during MMTT (total and incremental AUC0-300min)
Measured in minute * millimoles per liter (min*mmol/L).
Measured: Baseline to week 28
Change in insulin concentration during MMTT (total and incremental AUC0-300min)
Measured in minute * picomoles per liter (min*pmol/L).
Measured: Baseline to week 28
Change in C-peptide concentration during MMTT (total and incremental AUC0-300min)
Measured in minute * nanomole per liter (min*nmol/L).
Measured: Baseline to week 28
Change in glucagon concentration during MMTT (total and incremental AUC0-300min)
Measured in min*pmol/L.
Measured: Baseline to week 28
Change in fasting glucose concentration (MMTT pre-meal concentrations)
Measured in millimole per liter (mmol/L).
Measured: Baseline to week 28
Change in fasting insulin concentration (MMTT pre-meal concentrations)
Measured in picomole per milliliter (pmol/mL)
Measured: Baseline to week 28
Change in fasting C-peptide concentration (MMTT pre-meal concentrations)
Measured in nanomoles per liter (nmol/L).
Measured: Baseline to week 28
Change in fasting glucagon concentration (MMTT pre-meal concentrations)
Measured in picomoles per liter (pmol/L).
Measured: Baseline to week 28
Change in fasting proinsulin concentration (MMTT pre-meal concentrations)
Measured in pmol/L.
Measured: Baseline to week 28
Change in HbA1c
Measured as percentage points (%-points).
Measured: Baseline to week 28
Change in systolic and diastolic blood pressure
Measured in millimeters of mercury (mmHg).
Measured: Baseline to week 28
Number of Treatment Emergent Adverse Events (TEAEs)
Count of events.
Measured: Baseline to end of study (week 34)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start6 May 2024
- Primary completion28 Dec 2025
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 158 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
- NCT06403761
- Sponsor's protocol ID
- NN9388-7782
- Other IDs
- U1111-1300-1930, 2023-509483-20, 2023
- Status last verified
- Feb 2026
- First submitted
- 3 May 2024
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CagriSema, Semaglutide and Cagrilintide on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06403761
- Acronym / sponsor ID
- NN9388-7782
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 8 May 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 study will look at how CagriSema, semaglutide and cagrilintide regulate insulin effects in the body of people with type 2 diabetes (T2D). CagriSema is a new investigational medicine that combines two medicines called cagrilintide and semaglutide. Doctors may not yet prescribe CagriSema. Participants will either get CagriSema, semaglutide, cagrilintide, or a ''dummy'' medicine. Which treatment the participants will get is decided by chance. Participants will get the study medicine together with the current daily diabetes medicine metformin. Participants should not take other medicines for diabetes during the study. The study will last for about 42 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CagriSema | Experimental | Drug: Semaglutide, Drug: Cagrilintide, Drug: Placebo semaglutide, Drug: Placebo cagrilintideParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks. |
| Semaglutide | Experimental | Drug: Semaglutide, Drug: Placebo semaglutideParticipants will receive once-weekly s.c injections of semaglutide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks. |
| Cagrilintide | Experimental | Drug: Cagrilintide, Drug: Placebo cagrilintideParticipants will receive once-weekly s.c injections of cagrilintide at escalating doses every 4 weeks in a 16-week dose escalation period until target dose of CagriSema is achieved and maintained for 12 weeks. |
| Placebo | Placebo comparator | Drug: Placebo semaglutide, Drug: Placebo cagrilintideParticipants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 28 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female.
- Aged 18-75 years (both inclusive) at the time of signing informed consent.
- Diagnosed with type 2 diabetes greater than or equal to (>=) 180 days before screening.
- Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (<) 60 milliliter per minute per 1.73 square meter [ml/min/1.73 m^2]).
- Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole [mmol/mol]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c >= 7.0 % at screening.
Key exclusion criteria (4 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m^2 at screening.
- Treatment with any medication for the indication of T2D or weight management other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
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 |
|---|---|---|
| SemaglutideParticipants will receive once-weekly semaglutide subcutaneously. | Drug | CagriSema, Semaglutide |
| CagrilintideParticipants will receive once-weekly cagrilintide subcutaneously. | Drug | CagriSema, Cagrilintide |
| Placebo semaglutideParticipants will receive once-weekly placebo matched to semaglutide subcutaneously. | Drug | CagriSema, Placebo, Semaglutide |
| Placebo cagrilintideParticipants will receive once-weekly placebo matched to cagrilintide subcutaneously. | Drug | CagriSema, Cagrilintide, Placebo |
Primary outcome
To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC)
Time frame: Baseline to week 28
M-value from the HEC is calculated from glucose infusion rate (GIR) over the last 30 minutes of the clamp, corresponding to steady state. M-value is defined as: (GIR150-180 min normalised by body weight [milligram per minute per kilogram {mg/min/kg}]). Measured in mg/min/kg.
25 secondary outcomes
To compare the effect of CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC
Time frame: Baseline to week 28
To compare the effect of CagriSema versus placebo, CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC, normalised by lean body mass
Time frame: Baseline to week 28
Change in first-phase incremental insulin secretion rate (ISR0-8min) in hyperglycaemic clamp (HGC)
Time frame: Baseline to week 28
Change in second-phase insulin secretion rate (ISR20-120min) in HGC
Time frame: Baseline to week 28
Change in total insulin secretion rate (ISR0-120min) in HGC
Time frame: Baseline to week 28
Change in insulin secretion rate at fixed glucose concentration (ISRg) in HGC
Time frame: Baseline to week 28
Change in total insulin response (total AUC0-120 min) in HGC
Time frame: Baseline to week 28
Change in insulin response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Time frame: Baseline to week 28
Change in C-peptide response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Time frame: Baseline to week 28
Change in clamp disposition index (cDI) calculated from HEC and HGC
Time frame: Baseline to week 28
Change in cDI calculated from HEC and HGC,based on lean body mass
Time frame: Baseline to week 28
Change in β-cell glucose sensitivity (insulin secretion) from HGC
Time frame: Baseline to week 28
Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose)
Time frame: Baseline to week 28
Change in glucose concentration during MMTT (total and incremental AUC0-300min)
Time frame: Baseline to week 28
Change in insulin concentration during MMTT (total and incremental AUC0-300min)
Time frame: Baseline to week 28
Change in C-peptide concentration during MMTT (total and incremental AUC0-300min)
Time frame: Baseline to week 28
Change in glucagon concentration during MMTT (total and incremental AUC0-300min)
Time frame: Baseline to week 28
Change in fasting glucose concentration (MMTT pre-meal concentrations)
Time frame: Baseline to week 28
Change in fasting insulin concentration (MMTT pre-meal concentrations)
Time frame: Baseline to week 28
Change in fasting C-peptide concentration (MMTT pre-meal concentrations)
Time frame: Baseline to week 28
Change in fasting glucagon concentration (MMTT pre-meal concentrations)
Time frame: Baseline to week 28
Change in fasting proinsulin concentration (MMTT pre-meal concentrations)
Time frame: Baseline to week 28
Change in HbA1c
Time frame: Baseline to week 28
Change in systolic and diastolic blood pressure
Time frame: Baseline to week 28
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline to end of study (week 34)
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 27 Feb 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 Semaglutide and Cagrilintide in people with Diabetes Mellitus, Type 2, 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 6 inclusion and 4 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 27 Feb 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?
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?
To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC) (time frame: Baseline to week 28). 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 27 Feb 2026.