A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Phase 3

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: CagriSema (Cagrilintide B and Semaglutide I); Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

• Registration Number: NCT07011667
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-01
• Study First Submitted QC: 2025-06-01
• Study Start: 2025-06-03
• Study First Posted: 2025-06-09
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-12-15
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening.
• Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.

key

Exclusion Criteria

• Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CagriSema	CagriSema (Cagrilintide B and Semaglutide I)	Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks.
Placebo	CagriSema (Cagrilintide B and Semaglutide I)	Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.
Placebo	Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)	Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.

Primary Outcome Measures

Name	Time	Method
Relative change in body weight	From baseline (week 0) to week 80	Measured as percentage change.

Secondary Outcome Measures

Name	Time	Method
Change in CoEQ: craving for sweets score	From baseline (week 0) to week 80	Measured as score on a scale. 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.
Change in CoEQ: craving for savoury score	From baseline (week 0) to week 80	Measured as score on a scale. 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.
Change in CoEQ: hunger score	From baseline (week 0) to week 80	Measured as score on a scale. 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.
Change in CoEQ: satiety score	From baseline (week 0) to week 80	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.
Change in IWQOL-Lite-CT: psychosocial score	From baseline (week 0) to week 80	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. Psychosocial score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Change in IWQOL-Lite-CT: total score	From baseline (week 0) to week 80	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. Total score ranges from 0 to 100, with higher scores indicating better levels of functioning.
Change in SF-36v2 health survey acute: physical component summary score	From baseline (week 0) to week 80	Measured as score on a scale. The 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, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. The physical component summary score ranges from 6.1-79.7, with higher scores indicating better functional health and well-being.
Change in SF-36v2 health survey acute: mental component summary	From baseline (week 0) to week 80	Measured as score on a scale. The 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, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. The mental component summary score ranges from -3.8-78.7, with higher scores indicating better functional health and well-being.
Number of treatment emergent adverse events (TEAEs)	From baseline (week 0) to week 80	Measured as count of events.
Number of treatment emergent serious adverse events (TESAEs)	From baseline (week 0) to week 80	Measured as count of events.
Change in impact of weight on quality of life-lite for clinical trials (IWQOL-Lite-CT) physical function score	From baseline (week 0) to week 80	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.
Number of participants who achieve greater than or equals (≥) 20% weight reduction	From baseline (week 0) to week 80	Measured as count of participants.
Number of participants who achieve ≥ 25% weight reduction	From baseline (week 0) to week 80	Measured as count of participants.
Number of participants who achieve ≥ 30% weight reduction	From baseline (week 0) to week 80	Measured as count of participants.
Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)	From baseline (week 0) to week 80	Measured as count of participants.
Number of participants who achieve BMI < 30 kg/m^2	From baseline (week 0) to week 80	Measured as count of participants.
Change in waist circumference	From baseline (week 0) to week 80	Measured as centimeter (cm).
Change in systolic blood pressure	From baseline (week 0) to week 80	Measured as millimeters of mercury (mmHg).
Ratio to baseline in C-reactive protein (CRP)	From baseline (week 0) to week 80	Measured as ratio.
Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol	From baseline (week 0) to week 80	Measured as ratio.
Ratio to baseline in lipids: triglycerides	From baseline (week 0) to week 80	Measured as ratio.
Ratio to baseline in lipids: HDL	From baseline (week 0) to week 80	Measured as ratio.
Change in short form (SF)-36v2 physical function	From baseline (week 0) to week 80	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.
Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])	From baseline (week 0) to week 80	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. PGI-S at baseline is used to define the subgroup with "poor" physical function in IWQOL-Lite-CT.
Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)	From baseline (week 0) to week 80	Measured as score on a scale. 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, 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. PGI-S at baseline is used to define the subgroup with "poor" physical function in SF-36V2.
Number of participants who achieve ≥ 5% weight reduction	From baseline (week 0) to week 80	Measured as count of participants.
Number of participants who achieve ≥ 10% weight reduction	From baseline (week 0) to week 80	Measured as count of participants.
Number of participants who achieve ≥ 15% weight reduction	From baseline (week 0) to week 80	Measured as count of participants.
Change in waist to height ratio	From baseline (week 0) to week 80	Measured as ratio.
Change in waist to hip ratio	From baseline (week 0) to week 80	Measured as ratio.
Number of participants with reduction in weight category	From baseline (week 0) to week 80	Measured as count of participants. Reduction in weight categories: underweight, BMI \< 18.5 kg/m\^2; normal weight 18.5 kg/m\^2 ≤ BMI \< 25 kg/m\^2; overweight 25 kg/m\^2 ≤ BMI \< 30 kg/m\^2; obesity class I 30 kg/m\^2 ≤ BMI \< 35 kg/m\^2; obesity class II 35 kg/m\^2 ≤ BMI \< 40 kg/m\^2; obesity class III BMI ≥ 40 kg/m\^2.
Change in diastolic blood pressure	From baseline (week 0) to week 80	Measured as mmHg.
Ratio to baseline in lipids: total cholesterol	From baseline (week 0) to week 80	Measured as ratio.
Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol	From baseline (week 0) to week 80	Measured as ratio.
Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol	From baseline (week 0) to week 80	Measured as ratio.
Ratio to baseline in lipids: free fatty acids	From baseline (week 0) to week 80	Measured as ratio.
Change in control of eating questionnaire (CoEQ): craving control score	From baseline (week 0) to week 80	Measured as score on a scale. 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 control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.
Change in CoEQ: positive mood score	From baseline (week 0) to week 80	Measured as score on a scale. 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.
Change in IWQOL-Lite-CT: physical score	From baseline (week 0) to week 80	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 score ranges from 0 to 100, with higher scores indicating better levels of functioning.

Trial Locations

Locations (45)

FDRC; 🇺🇸 Costa Mesa, California, United States

Linda Vista Health Care Ctr; 🇺🇸 San Diego, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Northeast Research Institute; 🇺🇸 Fleming Island, Florida, United States

Jacksonville Ctr For Clin Res; 🇺🇸 Jacksonville, Florida, United States

South Broward Research LLC; 🇺🇸 Miramar, Florida, United States

Florida Inst For Clin Res LLC; 🇺🇸 Orlando, Florida, United States

Oviedo Medical Research, LLC; 🇺🇸 Oviedo, Florida, United States

Cnt for Diab,Obes, and Metab; 🇺🇸 Pembroke Pines, Florida, United States

Hope Clin Res & Wellness; 🇺🇸 Conyers, Georgia, United States

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