A Phase 3 interventional study of Cagrisema and Semaglutide in Obesity and Type 2 Diabetes, sponsored by Novo Nordisk A/S. Recruiting at 303 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
Exclusion Criteria:
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
Drug: Cagrisema
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
Drug: Cagrisema
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
Drug: Semaglutide
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Semaglutide will be administered subcutaneously.
Relative change in body weight
Measured as percentage (%).
Time frame: From randomisation (week 0) to end of treatment (week 72)
Relative change in body weight
Measured as %.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Change in Body Mass Index (BMI)
Measured as kilograms per square metre (kg/m\^2).
Time frame: From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Measured as count of participants.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve ≥25% weight reduction
Measured as count of participants.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve greater ≥ 20% weight reduction
Measured as count of participants.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Change in waist circumference
Measured in centimetre (cm).
Time frame: From randomisation (week 0) to end of treatment (week 72)
Mean change in body weight
Measured in kilograms (kg).
Time frame: From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Measured as count of participants.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve BMI <27 kg/m^2
Measured as count of participants.
Time frame: end of treatment (week 72)
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Measured as count of participants.
Time frame: At end of treatment (week 72)
Number of participants who achieve a waist-to-height ratio < 0.53
Measured as count of participants.
Time frame: At end of treatment (week 72)
Ratio to baseline : Total cholesterol
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Triglycerides
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Ratio to baseline: Free fatty acids
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Non-HDL cholesterol
Measured in terms of ratio.
Time frame: From baseline (week 0) to end of treatment (week 72)
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Measured as score on a scale. The 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, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Change in glycated haemoglobin (HbA1c)
Measured in %-points.
Time frame: From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve HbA1c <6.5%
Measured as count of participants.
Time frame: At end of treatment (week 72)
Number of participants who achieve normal HbA1c <5.7%
Measured as count of participants.
Time frame: At end of treatment (week 72)
Number of treatment-emergent adverse events (TEAEs)
Measured in number of events.
Time frame: From randomisation (week 0) to end of study (week 80)
Number of treatment-emergent serious adverse events (TESAEs)
Measured in number of events.
Time frame: From randomisation (week 0) to end of study (week 80)
Showing the first 100 of 303 sites across 19 countries.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Novo Nordisk A/S