A Phase 3 interventional study of Cagrilintide and Semaglutide in Type 2 Diabetes, sponsored by Novo Nordisk A/S. Completed at 61 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
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 274 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 week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
Drug: Cagrilintide · Drug: Semaglutide
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
Drug: Cagrilintide · Drug: Semaglutide
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks.
Drug: Placebo
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks
Drug: Placebo
Participants will receive once-weekly cagrilintide subcutaneously.
Participants will receive once-weekly semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Change in Glycated Haemoglobin (HbA1c)
Measured in percentage (%)- points.
Time frame: From baseline (week 0) to end of treatment (week 40)
Relative Change in Body Weight
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥15% Body Weight Reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Measured as count of participants.
Time frame: At end of treatment (week 40)
Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol)
Measured as count of participants.
Time frame: At end of treatment (week 40)
Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L).
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Insulin Dose
Measured in units (u).
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units
Measured as count of participants.
Time frame: At end of treatment (week 40)
Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
Measured in mmol/L.
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥5% Body Weight Reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥20% Body Weight Reduction
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Waist Circumference
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Diastolic Blood Pressure (DBP)
Measured in mmHg.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP)
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Triglycerides
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: HDL Cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Total Cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Free Fatty Acids
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score
Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The vitality score range is from 25.6 to 69.1.
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2: Physical Component Summary Score
Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for physical component summary is 6.1 to 79.7.
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2: Mental Component Summary Core
Measured as score points. SF-36v2 Acute measures HRQoL. The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The score range for mental component summary score is -3.8 to 78.7.
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36).
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Leptin
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Soluble Leptin Receptor
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter)
Measured as count of episodes.
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of Clinically Significant Hypoglycaemic Episodes (level 3)
Measured as count of episodes. Hypoglycaemic episodes (level 3) is hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold.
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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