AMBITION 2NCT07931547
A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease Treated With Once Daily Basal Insulin Alone or in Combination With Metformin, SGLT2i, or Both
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Change in glycated haemoglobin (HbA1c)
Timeframe: From baseline (week 0) to week 52
Secondary (7)
Relative change in body weight
Change in waist circumference
Change in triglycerides
Change in Non-high-density lipoprotein (Non-HDL) cholesterol
Change in high-sensitivity C-reactive protein (hsCRP)
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Change in systolic blood pressure
Change in 7-point self-measured plasma glucose (SMPG) profiles: Mean postprandial increment (over all meals)
Arms and interventions
PlaceboPlacebo comparator
Participants will receive placebo matched to zenagamtide subcutaneously.
ZenagamtideExperimental
Participants will receive zenagamtide subcutaneously.
Other: Placebo
Drugs: Zenagamtide
Sites
125 sites in 10 countries
United States 26, China 20, Japan 17, India 13, Turkey (Türkiye) 11, South Korea 10, Poland 9, Czechia 8, Germany 7, Brazil 4