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Clinical Trials in the EU / 2026-525182-53-00
Authorised Phase III

Zenagamtide use for the reduction of risk of major adverse cardiovascular events in people with established atherosclerotic cardiovascular disease and either overweight or obesity (AMBIENCE)

2026-525182-53-00 · tracked via the Priya Life Science EU tracker
Sponsor
Novo Nordisk A/S
Sponsor type
Pharmaceutical company
Therapeutic area
Cardiovascular Diseases
Decision date
16/09/2026
Enrollment target
320
Sites
Czechia

Condition studied

Atherosclerotic cardiovascular disease and either overweight or obesity

Investigational medicinal product(s)

NNC0487-0111 B 10143NNC0487-0111 B 10141NNC0487-0111 B 10144NNC0487-0111 B 10146Placebo (Zenagamtide)NNC0487-0111 B 10145NNC0487-0111 B 10142

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

Time from randomisation to first occurrence of a 4-P composite MACE endpoint consisting of: - CV death - Non-fatal MI - Non-fatal stroke - HF hospitalisationa or urgent HF visit

Endpoint detail

Time from randomisation to first occurrence of an expanded composite 5-P MACE endpoint consisting of: - All-cause death - Non-fatal MI - Non-fatal stroke - HF hospitalisationa or urgent HF visit - Coronary revascularization, Time from randomisation to first occurrence of a composite 3-P MACE endpoint consisting of: - CV death - Non-fatal MI - Non-fatal stroke, Change in eGFR (creatinine and cystatin C-based CKD-EPI 2021) for participants with baseline eGFR<60 mL/min/1.73 m2, Time from randomisation to all-cause death, Time from randomisation to CV death, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI, CCI

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-525182-53-00 on CTIS ↗ ← All trials in the EU