AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

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.

It had two arms (groups): Zenagamtide (experimental) and Insulin glargine U-100 (active comparator).

Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.

Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1778 planned participants were the target.

It was open to people of any sex aged from 45 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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.

The full record lists 20 inclusion and 9 exclusion criteria; among the exclusions: myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening; planned coronary, carotid or peripheral artery revascularisation; chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-08-24 with completion listed for 2028-07-31.

It ran at 330 sites in United States (109), China (34), Poland (25), India (21), Argentina (19) and Brazil (17).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Relative change in body weight, Change in waist circumference, Change in systolic blood pressure, Change in high-sensitivity C-reactive protein (hsCRP), Change in Triglycerides and Change in Non-high-density lipoprotein (non-HDL) cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 1778 people.

With 1778 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.