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AMAZE 8: NNC0487-0111 vs Semaglutide in T2D and Overweight/Obesity
NCT07400107Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- May 2026
- Primary completion
- Dec 2028
- Countries
- 14
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Small Molecules
- Drugs
- amycretin
- Conditions
- obesitytype 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of amycretin in obesity and type 2 diabetes mellitus (T2DM), sponsored by Novo Nordisk. Primary endpoint: Relative change in body weight at 84 weeks. Planned start May 2026; status: not yet recruiting.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults (18+) with type 2 diabetes (HbA1c 7-10%) and overweight or obesity, on stable lifestyle or 0-3 OADs, excluding those with severe renal impairment (eGFR < 30), recent retinopathy treatment, or prior GLP-1/GIP/amylin therapy.
04
Endpoints
Primary
Relative change in body weight
Secondary
Change in waist circumference
Change in systolic blood pressure
Change in body weight
Change in body mass index
Achievement of HbA1c < 7.0%
Achievement of HbA1c ≤ 6.5%
Achievement of HbA1c < 5.7%
Change in fasting plasma glucose
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