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)
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)
This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.
Inclusion Criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
Male or female (sex assigned at birth, inclusive of all gender identities).
Age 45 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.
Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.
Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):
Prior myocardial infarction (MI)
Documented coronary artery disease defined by at least one of the following:
-≥ 50% stenosis of coronary artery on angiography or other imaging modality.
Ischaemia documented by stress test with any imaging modality.
Prior unstable angina with electrocardiogram (ECG) changes.
Prior coronary artery bypass graft or prior percutaneous coronary intervention.
Prior stroke (ischemic or haemorrhagic stroke).
History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.
Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest.
Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound.
Prior revascularisation procedure of a lower extremity peripheral artery.
Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
Exclusion Criteria:
Diabetes- or weight related:
clinicaltrials@novonordisk.com(+1) 866-867-7178
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