AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Purpose
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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) greater than or equal to ≥ 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 before screening.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NNC0487-0111 |
Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
|
Placebo Comparator Placebo |
Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S