Obesity, Overweight
Conditions
Brief summary
The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.
Interventions
Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Sponsors
Study design
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Inclusion criteria
* Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent.
Exclusion criteria
* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From week 0 to week 84 | Measured as percentage (%) change in body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | From week 0 to week 84 | Measured as centimetre (cm). |
Countries
United States
Contacts
Novo Nordisk A/S