A Phase 1 interventional study of Semaglutide and Cagrilintide in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 158 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Semaglutide · Drug: Cagrilintide · Drug: Placebo semaglutide · Drug: Placebo cagrilintide
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.
Drug: Semaglutide · Drug: Placebo semaglutide
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.
Drug: Cagrilintide · Drug: Placebo cagrilintide
Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 28 weeks.
Drug: Placebo semaglutide · Drug: Placebo cagrilintide
Participants will receive once-weekly semaglutide subcutaneously.
Participants will receive once-weekly cagrilintide subcutaneously.
Participants will receive once-weekly placebo matched to semaglutide subcutaneously.
Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
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.
Time frame: Baseline to week 28
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.
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
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.
Time frame: 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).
Time frame: Baseline to week 28
Change in second-phase insulin secretion rate (ISR20-120min) in HGC
Measured in pmol/min/m\^2.
Time frame: Baseline to week 28
Change in total insulin secretion rate (ISR0-120min) in HGC
Measured in pmol/min/m\^2.
Time frame: Baseline to week 28
Change in insulin secretion rate at fixed glucose concentration (ISRg) in HGC
Measured in pmol/min/m\^2.
Time frame: Baseline to week 28
Change in total insulin response (total AUC0-120 min) in HGC
Measured in minute \* picomoles per liter (min\*pmol/L).
Time frame: Baseline to week 28
Change in insulin response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Measured in min\*pmol/L.
Time frame: Baseline to week 28
Change in C-peptide response to arginine (incremental insulin AUCarginine,0-10min) in HGC
Measured in min\*nmol/L.
Time frame: 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).
Time frame: 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.
Time frame: 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/\[mmol/L\]).
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)
Measured in pmol/min/m\^2/(mmol/L).
Time frame: Baseline to week 28
Change in glucose concentration during MMTT (total and incremental AUC0-300min)
Measured in minute \* millimoles per liter (min\*mmol/L).
Time frame: Baseline to week 28
Change in insulin concentration during MMTT (total and incremental AUC0-300min)
Measured in minute \* picomoles per liter (min\*pmol/L).
Time frame: 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).
Time frame: Baseline to week 28
Change in glucagon concentration during MMTT (total and incremental AUC0-300min)
Measured in min\*pmol/L.
Time frame: Baseline to week 28
Change in fasting glucose concentration (MMTT pre-meal concentrations)
Measured in millimole per liter (mmol/L).
Time frame: Baseline to week 28
Change in fasting insulin concentration (MMTT pre-meal concentrations)
Measured in picomole per milliliter (pmol/mL)
Time frame: Baseline to week 28
Change in fasting C-peptide concentration (MMTT pre-meal concentrations)
Measured in nanomoles per liter (nmol/L).
Time frame: Baseline to week 28
Change in fasting glucagon concentration (MMTT pre-meal concentrations)
Measured in picomoles per liter (pmol/L).
Time frame: Baseline to week 28
Change in fasting proinsulin concentration (MMTT pre-meal concentrations)
Measured in pmol/L.
Time frame: Baseline to week 28
Change in HbA1c
Measured as percentage points (%-points).
Time frame: Baseline to week 28
Change in systolic and diastolic blood pressure
Measured in millimeters of mercury (mmHg).
Time frame: Baseline to week 28
Number of Treatment Emergent Adverse Events (TEAEs)
Count of events.
Time frame: Baseline to end of study (week 34)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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