Comparing Zenagamtide with Insulin glargine U-100 for type 2 diabetes
Official title: 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
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)
Interventions
Zenagamtide
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
Insulin glargine U-100
Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).
Canadian Sites (10)
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
University of Alberta_Edmonton
Edmonton, Alberta, Canada
CARe Clinic Ltd.
Red Deer, Alberta, Canada
Medical Arts Health Research Group_Kelowna_0
Kelowna, British Columbia, Canada
Kelowna Health and Memory Centre Ltd.
Kelowna, British Columbia, Canada
Care Access Cape Breton
Sydney, Nova Scotia, Canada
Bluewater Clin Res Group Inc
Sarnia, Ontario, Canada
Stouffville Medical Research Institute
Stouffville, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, Canada
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
- +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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
- −Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed before screening or in the period between screening and randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- −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.
- −Diabetes- or weight related:
- −Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
- −Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.
- −Known hypoglycaemic unawareness as indicated by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → according to Clarke's questionnaire question.
- −Any episodes of diabetic ketoacidosis before screening.
- −Uncontrolled thyroid disease as per investigator's discretion.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Zenagamtide, Insulin glargine U-100.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 45 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,778 people.
The study is currently expected to finish around September 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c) — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to week 52.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07797335 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ZenagamtideDrug
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Insulin glargine U-100Drug
Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 45 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to week 52.
The study as a whole is currently expected to finish around 2028-09-20.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,778 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Red Deer, Alberta, Canada; Kelowna, British Columbia, Canada; Sydney, Nova Scotia, Canada; Sarnia, Ontario, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (10)
Henry Ford Health System
Detroit, Michigan, United States
Elite Research Center
Flint, Michigan, United States
Arcturus Healthcare, PLC.
Troy, Michigan, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, United States
Central New York Clinical Research CNYCR
Manlius, New York, United States
Mid Hudson Med Res-New Windsor
New Windsor, New York, United States
Harlem Cardiology_Madison ave
New York, New York, United States
NYC Health + Hospitals/Lincoln
The Bronx, New York, United States
Prime Global Research Inc.
The Bronx, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.