Obesity, Type 2 Diabetes
Conditions
Brief summary
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
Interventions
DRUGCagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
DRUGSemaglutide
Semaglutide will be administered subcutaneously.
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
: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * BMI≥ 35.0 kg/m\^2. * Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
Exclusion criteria
* A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records. * Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From randomisation (week 0) to end of treatment (week 72) | Measured as percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who achieve greater than or equal to (≥) 30% weight reduction | From randomisation (week 0) to end of treatment (week 72) | Measured as count of participants. |
| Number of participants who achieve ≥25% weight reduction | From randomisation (week 0) to end of treatment (week 72) | Measured as count of participants. |
| Number of participants who achieve greater ≥ 20% weight reduction | From randomisation (week 0) to end of treatment (week 72) | Measured as count of participants. |
| Change in waist circumference | From randomisation (week 0) to end of treatment (week 72) | Measured in centimetre (cm). |
| Mean change in body weight | From randomisation (week 0) to end of treatment (week 72) | Measured in kilograms (kg). |
| Number of participants who achieve a BMI less than (<) 30 kg/m^2 | From randomisation (week 0) to end of treatment (week 72) | Measured as count of participants. |
| Number of participants who achieve BMI <27 kg/m^2 | end of treatment (week 72) | Measured as count of participants. |
| Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2 | At end of treatment (week 72) | Measured as count of participants. |
| Number of participants who achieve a waist-to-height ratio < 0.53 | At end of treatment (week 72) | Measured as count of participants. |
| Ratio to baseline : Total cholesterol | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Ratio to baseline : High density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Ratio to baseline : Low density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Ratio to baseline : Triglycerides | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Ratio to baseline: Free fatty acids | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Ratio to baseline : Non-HDL cholesterol | From baseline (week 0) to end of treatment (week 72) | Measured in terms of ratio. |
| Relative change in body weight | From randomisation (week 0) to end of treatment (week 72) | Measured as %. |
| Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function | From randomisation (week 0) to end of treatment (week 72) | 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 Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function | From randomisation (week 0) to end of treatment (week 72) | 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 glycated haemoglobin (HbA1c) | From randomisation (week 0) to end of treatment (week 72) | Measured in %-points. |
| Number of participants who achieve HbA1c <6.5% | At end of treatment (week 72) | Measured as count of participants. |
| Number of participants who achieve normal HbA1c <5.7% | At end of treatment (week 72) | Measured as count of participants. |
| Number of treatment-emergent adverse events (TEAEs) | From randomisation (week 0) to end of study (week 80) | Measured in number of events. |
| Change in Body Mass Index (BMI) | From randomisation (week 0) to end of treatment (week 72) | Measured as kilograms per square metre (kg/m\^2). |
| Number of treatment-emergent serious adverse events (TESAEs) | From randomisation (week 0) to end of study (week 80) | Measured in number of events. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed