Actively Recruiting
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity AMAZE 1
Led by Novo Nordisk A/S · Updated on 2026-06-02
1150
Participants Needed
72
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating people with excess body weight. This Phase 3 clinical trial compares the medicine with a placebo, both given as weekly injections under the skin. The study focuses on how these treatments affect weight loss and other health measures related to obesity. Participants will be randomly assigned to receive one of four dose levels of NNC0487-0111 or a matching placebo. Both treatments are given once a week using a pre-filled pen injector applied to the thigh, abdomen, or upper arm. The treatment is combined with a reduced-calorie diet and increased physical activity. The study includes an initial treatment period lasting 84 weeks, with follow-up assessments continuing to week 136 and safety monitoring through week 140. During the study, participants will undergo regular evaluations including body weight, waist circumference, blood pressure, blood sugar levels, cholesterol, and quality of life surveys. Researchers will track adverse events and treatment effects at multiple time points from the start up to week 140. Participants will be closely monitored for safety throughout the trial, which runs from the baseline visit through extended follow-up periods.
CONDITIONS
Brief Title
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female (sex at birth).
- Informed consent obtained before any study-related activities.
- History of at least one unsuccessful attempt to lose body weight by dieting.
You will not qualify if you...
- HbA1c 6.5% (48 mmol/mol) or higher at screening.
- History of type 1 or type 2 diabetes mellitus.
- Prior treatment with GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, or amylin analogues before screening.
Research Team
N
Novo Nordisk
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