Obesity
Conditions
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.
Interventions
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants in the main phase will be randomised in double blinded manner to receive either CagriSema or matching placebo. In the extension phase, eligible participants will be re-randomised and enter the open label extension phase. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
key 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to week 80 | Measured as percentage change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight in women | From baseline (week 0) to week 80 | Measured as percentage change. |
| 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 BMI < 30 kg/m^2 | 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. |
| 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 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. |
| 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 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: 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. |
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed