Obesity, Overweight, Type 2 Diabetes
Conditions
Brief summary
This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.
Interventions
DRUGCagrilintide
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Female or male (sex at birth). * Age 18 years or above at the time of signing the informed consent. * History of at least one self-reported unsuccessful dietary effort to lose body weight.(a\*) * Body mass index (BMI) \>= 27.0 kilogram per square meter (kg/m\^2). * Diagnosed with type 2 diabetes \>= 180 days before screening.(a\*) * Treatment with either lifestyle intervention(a\*), or: * Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a\*) * For up to 30% of participants the following concomitant medication is allowed: * Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a\*) and/or * Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day \[U/day\]) stable for at least 90 days before screening.(a\*) Key
Exclusion criteria
* Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\*) * Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(a\*) * Previous dosing of marketed or non-marketed amylin-based compounds.(a\*) (a\*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 64) | Measured as percentage (%) of body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with achievement of >= 10% body weight reduction (yes/no) | From baseline (week 0) to end of treatment (week 64) | Measured as count of participants. |
| Number of participants with achievement of >= 15% body weight reduction (yes/no) | From baseline (week 0) to end of treatment (week 64) | Measured as count of participants. |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 64) | Measured as centimeter (cm). |
| Ratio to baseline in lipids: triglycerides | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Ratio to baseline in high sensitivity C-reactive protein (hsCRP) | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 64) | Measured as percentage of HbA1c. |
| Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score | From baseline (week 0) to end of treatment (week 64) | 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. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100. |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 64) | Measured as millimeter of mercury (mmHg). |
| Change in body weight | From baseline (week 0) to end of treatment (week 64) | Measured as kilogram (kg). |
| Number of participants with achievement of >= 5% body weight reduction (yes/no) | From baseline (week 0) to end of treatment (week 64) | Measured as count of participants. |
| Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score | From baseline (week 0) to end of treatment (week 64) | Measured as score on a scale. 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, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7. |
| Change in SF-36v2® mental component summary score | From baseline (week 0) to end of treatment (week 64) | Measured as score on a scale. 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, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7. |
| Change in IWQOL-Lite-CT total score | From baseline (week 0) to end of treatment (week 64) | 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. Higher scores indicate better levels of functioning. The total score ranges from 0-100. |
| Number of participants with achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT physical function score | From baseline (week 0) to end of treatment (week 64) | Measured as count of participants. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100. |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to end of treatment (week 64) | Measured as mmHg. |
| Ratio to baseline in lipids: total cholesterol | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Ratio to baseline in lipids: non-HDL cholesterol | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Ratio to baseline in lipids: free fatty acids | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L) | From baseline (week 0) to end of treatment (week 64) | Measured as mmol/L. |
| Change in FPG in milligram per deciliter (mg/dL) | From baseline (week 0) to end of treatment (week 64) | Measured as mg/dL. |
| Ratio to baseline in fasting serum insulin | From baseline (week 0) to end of treatment (week 64) | Measured as ratio. |
| Number of treatment emergent adverse events | From baseline (week 0) to end of study (week 71) | Measured as count of events. |
| Number of treatment emergent serious adverse events (TESAEs) | From baseline (week 0) to end of study (week 71) | Measured as count of events. |
| Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter | From baseline (week 0) to end of study (week 71) | Measured as count of events. |
| Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | From baseline (week 0) to end of study (week 71) | Measured as count of events. |
Countries
Argentina, Canada, Croatia, Czechia, Hungary, Romania, Slovakia, South Korea, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Transparency' (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed