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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
609
CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
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
Relative change in body weight
Measured as percentage change.
Time frame: From baseline (week 0) to week 80
Relative change in body weight in women
Measured as percentage change.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve greater than or equals (≥) 20% weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 25% weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 30% weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve BMI < 30 kg/m^2
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
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)
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Change in waist circumference
Measured as centimeter (cm).
Time frame: From baseline (week 0) to week 80
Change in systolic blood pressure
Measured as millimeters of mercury (mmHg).
Time frame: From baseline (week 0) to week 80
Ratio to baseline in C-reactive protein (CRP)
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: triglycerides
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: HDL
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Change in impact of weight on quality of life-lite for clinical trials (IWQOL-Lite-CT) physical function score
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 baseline (week 0) to week 80
Change in short form (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 baseline (week 0) to week 80
Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])
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.
Time frame: From baseline (week 0) to week 80
Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)
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.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 5% weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 10% weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Number of participants who achieve ≥ 15% weight reduction
Measured as count of participants.
Time frame: From baseline (week 0) to week 80
Change in waist to height ratio
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Change in waist to hip ratio
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Number of participants with reduction in weight category
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.
Time frame: From baseline (week 0) to week 80
Change in diastolic blood pressure
Measured as mmHg.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: total cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Ratio to baseline in lipids: free fatty acids
Measured as ratio.
Time frame: From baseline (week 0) to week 80
Change in control of eating questionnaire (CoEQ): craving control score
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.
Time frame: From baseline (week 0) to week 80
Change in CoEQ: positive mood score
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.
Time frame: From baseline (week 0) to week 80
Change in CoEQ: craving for sweets score
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.
Time frame: From baseline (week 0) to week 80
Change in CoEQ: craving for savoury score
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.
Time frame: From baseline (week 0) to week 80
Change in CoEQ: hunger score
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.
Time frame: From baseline (week 0) to week 80
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 80
Change in IWQOL-Lite-CT: physical score
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.
Time frame: From baseline (week 0) to week 80
Change in IWQOL-Lite-CT: psychosocial score
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.
Time frame: From baseline (week 0) to week 80
Change in IWQOL-Lite-CT: total score
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.
Time frame: From baseline (week 0) to week 80
Change in SF-36v2 health survey acute: physical component summary score
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.
Time frame: From baseline (week 0) to week 80
Change in SF-36v2 health survey acute: mental component summary
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.
Time frame: From baseline (week 0) to week 80
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to week 80
Number of treatment emergent serious adverse events (TESAEs)
Measured as count of events.
Time frame: From baseline (week 0) to week 80
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