Type 2 Diabetes study: Zenagamtide vs Insulin glargine U-100
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
ClinicalTrials.gov ID: NCT07797335
What this study is testing
What is Zenagamtide?
An investigational once‑weekly injectable medicine being studied for type 2 diabetes.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares how well zenagamtide works and how safe it is compared with insulin glargine in people with type 2 diabetes who are at higher risk of heart and blood vessel problems.
- Who it's for
- Adults with type 2 diabetes who are already taking 1 to 3 diabetes medications and have a higher risk of heart and blood vessel disease.
- What's involved
- Participants receive weekly injections of either zenagamtide or insulin glargine, chosen randomly. They will have regular visits for blood tests and other routine monitoring.
- Time commitment
- The study lasts several months, with weekly injections and periodic clinic visits for monitoring and testing.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of 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...
You likely can't join if
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based...
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial...
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
See the full eligibility 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...
- 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.
- 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.
- 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)
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening.
- 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...
- 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 screening or are...
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
- Any episodes of diabetic ketoacidosis before screening.
- Uncontrolled thyroid disease as per investigator's discretion.
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Montgomery, Alabama, United States
- Lancaster, California, United States
- Lincoln, California, United States
- Lomita, California, United States
- Los Alamitos, California, United States
- Northridge, California, United States
- San Diego, California, United States
- San Dimas, California, United States
- Spring Valley, California, United States
- Clearwater, Florida, United States
- Hollywood, Florida, United States
- Lakeland, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Miramar, Florida, United States
- Ocala, Florida, United States
- Saint Augustine, Florida, United States
- Albany, Georgia, United States
- Idaho Falls, Idaho, United States
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fairhope, Alabama, United States; Montgomery, Alabama, United States; Lancaster, California, United States; Lincoln, California, United States; Lomita, California, United States; Los Alamitos, California, United States and 45 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.