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Efficacy and safety of zenagamtide s.c. once weekly compared to insulin glargine s.c. once daily in participants with type 2 diabetes and increased cardiovascular risk inadequately controlled on 1–3 oral glucose-lowering medications (AMBITION 7)

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525209-11-00
Enrollment
110
Registered
2026-09-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-04

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

Conditions

Type 2 diabetes (T2D) and increased cardiovascular (CV) risk not in adequate glycaemic control on 1–3 marketed oral glucose lowering medications.

Brief summary

"Change in haemoglobin A1c (HbA1c) from baseline (week 0) to week 52 'Time to first occurrence of a 4-point MACE endpoint consisting of: -CV death -non-fatal myocardial infarction -non-fatal stroke -hospitalisation for unstable angina from baseline (week 0) to CCI (up to 104 weeks or more)"

Detailed description

- Relative change in body weight - Change in HbA1c from baseline (week 0) to week 52, Time to first occurrence of a 3-point MACE endpoint consisting of: -CV death -non-fatal myocardial infarction -non-fatal stroke from baseline (week 0) to CCI (up to 104 weeks or more), - Change in waist circumference - Change in systolic blood pressure - Change in high-sensitivity C-reactive protein (hsCRP) - Change in Triglycerides and Non-high-density lipoprotein (non-HDL) cholesterol from baseline (week 0) to week 52, CCI, CCI

Interventions

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
"Change in haemoglobin A1c (HbA1c) from baseline (week 0) to week 52 'Time to first occurrence of a 4-point MACE endpoint consisting of: -CV death -non-fatal myocardial infarction -non-fatal stroke -hospitalisation for unstable angina from baseline (week 0) to CCI (up to 104 weeks or more)"

Secondary

MeasureTime frame
- Relative change in body weight - Change in HbA1c from baseline (week 0) to week 52, Time to first occurrence of a 3-point MACE endpoint consisting of: -CV death -non-fatal myocardial infarction -non-fatal stroke from baseline (week 0) to CCI (up to 104 weeks or more), - Change in waist circumference - Change in systolic blood pressure - Change in high-sensitivity C-reactive protein (hsCRP) - Change in Triglycerides and Non-high-density lipoprotein (non-HDL) cholesterol from baseline (week 0) to week 52, CCI, CCI

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 5, 2026