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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525182-53-00
Enrollment
1520
Registered
2026-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease and either overweight or obesity

Brief summary

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

Detailed description

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

Interventions

DRUGNNC0487-0111 B 10143
DRUGNNC0487-0111 B 10141
DRUGNNC0487-0111 B 10144
DRUGNNC0487-0111 B 10146
DRUGPlacebo (Zenagamtide)
DRUGNNC0487-0111 B 10145
DRUGNNC0487-0111 B 10142

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
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—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 19, 2026