Trial comparing treatments 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
ClinicalTrials.gov ID: NCT07797335
What this study is testing
What is Zenagamtide?
Zenagamtide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment 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
- 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.
- 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.
- 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 criteria before screening. However...
- 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...
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.
- 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)
- 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 criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term...
- 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's taking place
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Montgomery, Alabama, United States
- Scottsdale, Arizona, United States
- Lancaster, California, United States
- Lincoln, California, United States
- Lomita, California, United States
- Los Alamitos, California, United States
- Los Angeles, 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
- Crystal River, Florida, United States
- Delray Beach, Florida, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Lakeland, Florida, United States
- Miami, Florida, United States
+ 256 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 - 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?
Study sites include Birmingham, Alabama, United States; Fairhope, Alabama, United States; Montgomery, Alabama, United States; Scottsdale, Arizona, United States; Lancaster, California, United States; Lincoln, California, United States and 270 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.