A Phase 3 interventional study of Cagrilintide and Semaglutide in Obesity, sponsored by Novo Nordisk A/S. Active, not recruiting at 36 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's planned enrollment of 400 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity 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) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.
Drug: Cagrilintide · Drug: Semaglutide
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.
Drug: Placebo cagrilintide · Drug: Placebo semaglutide
Participants will receive cagrilintide subcutaneously.
Participants will receive semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
Relative change in body weight
Measured in percentage (%).
Time frame: From baseline (week 0) to week 104
Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Number of participants who achieve >= 25 percent body weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Number of participants who achieve >= 30 percent body weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Change in waist circumference
Measured in centimeter (cm).
Time frame: From baseline (week 0) to week 104
Change in waist to height ratio
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg).
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Total Cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Triglycerides
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Free fatty acids
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Ratio to Baseline in Lipids: Non-HDL cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Change in Body Mass Index (BMI)
Measured in kilograms per meter square (kg/m\^2).
Time frame: From baseline (week 0) to week 104
Number of participants who achieve BMI less than 30 kg/m^2
Measured as count of participants.
Time frame: At week 104
Change in Glycated Haemoglobin (HbA1c) (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in HbA1c (millimoles per mole [mmol/mol])
Measured in mmol/mol.
Time frame: From baseline (week 0) to week 104
Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])
Measured as mmol/L.
Time frame: From baseline (week 0) to week 104
Change in FPG (milligrams per deciliter [mg/dL])
Measured as mg/dL.
Time frame: From baseline (week 0) to week 104
Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline
Measured in days.
Time frame: From baseline (week 0) to week 104
Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline
Measured in days.
Time frame: From baseline (week 0) to week 104
Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Time to T2D diagnosis as per ADA guideline
Measured in days.
Time frame: From baseline (week 0) to week 104
Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score
Measured in percentage of risk. American College of Cardiology/American Heart Association (ACC/AHA) risk estimator calculates 10 year risk of atherosclerotic cardiovascular disease (ASCVD) using a formula which includes age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0, maximum score 100 where higher score indicates higher risk of 10-year risk of atherosclerotic cardiovascular disease (ASCVD).
Time frame: From baseline (week 0) to week 104
Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)
Measured as count of participants.
Time frame: From baseline (week 0) to week 104
Ratio to baseline in C-reactive protein (CRP)
Measured as ratio.
Time frame: From baseline (week 0) to week 104
Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])
Measured in kg.
Time frame: From baseline (week 0) to week 104
Change in total fat mass by DXA relative to total body mass (kg)
Measured in kg.
Time frame: From baseline (week 0) to week 104
Change in total fat mass by DXA absolute to total body mass (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in total fat mass by DXA relative to total body mass (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)
Measured in percentage.
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)
Measured in percentage.
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA absolute to total body mass (kg)
Measured in kg.
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA relative to total body mass (kg)
Measured in kg.
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA absolute to total body mass (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in lean body mass by DXA relative to total body mass (percentage points)
Measured in percentage points.
Time frame: From baseline (week 0) to week 104
Change in Short Form (SF)-36 Physical functioning score
Measured as score points. 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. The 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 baseline (week 0) to week 104
Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT): Physical Function Score
Measured as score points. 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 baseline (week 0) to week 104
Change in IWQOL-Lite-CT: Physical Score
Measured as score points. 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 score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Time frame: From baseline (week 0) to week 104
Change in IWQOL-Lite-CT: Psychosocial score
Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Psychosocial score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Time frame: From baseline (week 0) to week 104
Change in IWQOL-Lite-CT: Total score
Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Total score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Time frame: From baseline (week 0) to week 104
Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score
Measured as score points. IWDAQ is an 18-item measure that uses an adaptive design to provide a personalised assessment of daily activity limitations associated with excess weight. At the baseline assessment the study participants choose the 3 activities (items) they would most like to improve the weight loss and rate the degree of limitation in each of these activities. At follow-up assessments, the study participants again rate the degree of current limitation in each of the same 3 activities. The measure yields the IWDAQ composite score with a score range from 3 to 15 with higher scores indicating greater personalised activity limitation.
Time frame: From baseline (week 0) to week 104
Change in Control of Eating questionnaire (CoEQ): Craving Control score
Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. 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); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
Time frame: From baseline (week 0) to week 104
Change in CoEQ: Positive Mood score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. 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); single items that address hunger and satiety (0-10). For the Positive Mood subscale, item 6 'How anxious have you felt?' is reversed.
Time frame: From baseline (week 0) to week 104
Change in CoEQ: Craving for Sweets score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. 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); single items that address hunger and satiety (0-10). For the craving sweets food subscale, higher score represents a greater level of craving.
Time frame: From baseline (week 0) to week 104
Change in CoEQ: Craving for Savoury score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. 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); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving.
Time frame: From baseline (week 0) to week 104
Change in CoEQ: Hunger score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. 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); single items that address hunger and satiety (0-10). For the hunger subscale, higher score represents a greater level of craving.
Time frame: From baseline (week 0) to week 104
Change in CoEQ: Satiety score
Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. 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); single items that address hunger and satiety (0-10). For the satiety subscale, higher score represents a greater level of craving.
Time frame: From baseline (week 0) to week 104
CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to week 104
CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as count of events.
Time frame: From baseline (week 0) to week 104
CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TEAEs
Measured as count of events.
Time frame: From week 104 to end of study (week 162)
CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TESAEs
Measured as count of events.
Time frame: From week 104 to end of study (week 162)
CagriSema 2.4 mg/2.4 mg: Number of TEAEs
Measured as count of events.
Time frame: From week 104 to end of study (week 162)
CagriSema 2.4 mg/2.4 mg: Number of TESAEs
Measured as count of events.
Time frame: From week 104 to end of study (week 162)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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