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
Recruiting · NCT07797335 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Insulin glargine U-100Zenagamtide
What this trial is about
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.
Who can take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
- 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 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.
- 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 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 randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- 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.
Where it is running
60 locations listed across 28 US states.
- Univ of Alabama Birmingham - Birmingham, Alabama, United States
- Eastern Shore Rsrch Inst, LLC - Fairhope, Alabama, United States
- Chambliss Clinical Trials, LLC - Montgomery, Alabama, United States
- Honor Health - Scottsdale, Arizona, United States
- First Valley Medical Group - Lancaster, California, United States
- Headlands Research CTR Lincoln - Lincoln, California, United States
- Torrance Clin Res Inst, Inc. - Lomita, California, United States
- Pacific Clinical Studies - Los Alamitos, California, United States
- VAGLAHS Clinical Research Center (CRC) - Los Angeles, California, United States
- Valley Clinical Trials, Inc. - Northridge, California, United States
- Paradigm Clinical Research - San Diego, California, United States
- N America Res Inst - San Dimas - San Dimas, California, United States
- Encompass Clinical Research_Spring Valley - Spring Valley, California, United States
- Innovative Research of W FL - Clearwater, Florida, United States
- Nature Coast Clin Rsrch_Crystal River - Crystal River, Florida, United States
- Florida Premier Cardiology - Delray Beach, Florida, United States
- Encore Medical Research LLC - Hollywood, Florida, United States
- East Coast Institute For Research - Jacksonville, Florida, United States
- Jacksonville Ctr for Clin Res - Jacksonville, Florida, United States
- Clinical Research of Cent FL - Lakeland, Florida, United States
- Life Spring Research Foundation LLC - Miami, Florida, United States
- Optimus U, Corp - Miami, Florida, United States
- Flourish Research - North Miami - Miami, Florida, United States
- Inpatient Research Clinic LLC - Miami Lakes, Florida, United States
- San Marcus Res Clin Miami Lakes - Miami Lakes, Florida, United States
- Trujillo Medical Centers - Miramar, Florida, United States
- Suncoast Clinical Research, Inc. - New Port Richey, Florida, United States
- Ocala Cardiovascular Research - Ocala, Florida, United States
- Suncoast Clinical Research, Inc. - Palm Harbor, Florida, United States
- Suncoast Research Associates LLC - Pembroke Pines, Florida, United States
- St Johns Center for Clin. Res - Saint Augustine, Florida, United States
- Javara/Privia Med Grp GA,LLC - Albany, Georgia, United States
- David Kavtaradze MD, Inc. - Cordele, Georgia, United States
- Atlanta Heart Specialist - Tucker, Georgia, United States
- Rocky Mountain Diab&Osteo Ctr - Idaho Falls, Idaho, United States
- Elevate Clinical Research - Gurnee, Illinois, United States
- Chicago Medical Research LLC - Hazel Crest, Illinois, United States
- Genesis Orthopedics & Sports Medicine - Oak Brook, Illinois, United States
- Methodist Medical Center of Illinois - Peoria, Illinois, United States
- American Health Network of IN LLC_Franklin - Franklin, Indiana, United States
- American Health Network of Indiana, LLC_Greenfield - Greenfield, Indiana, United States
- American Health Network of IN LLC - Muncie, Indiana, United States
- West Broadway Clinic - Council Bluffs, Iowa, United States
- University of Iowa Prev Inter Ctr - Iowa City, Iowa, United States
- Iowa Diab & Endo Res Center - West Des Moines, Iowa, United States
- Cotton O'Neil Diab & Endo Ctr - Topeka, Kansas, United States
- The Research Group of Lexington LLC - Lexington, Kentucky, United States
- Louisiana Heart Center - Covington, Louisiana, United States
- Ascension Saint Agnes Heart Ca - Baltimore, Maryland, United States
- MedStar Good Samaritan Hosp - Baltimore, Maryland, United States
- Brigham & Women's Hospital - Boston, Massachusetts, United States
- 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
- Johnson County ClinTrials - Kansas City, Missouri, United States
- Amicis Centers of Clinical Research - St Louis, Missouri, United States
- Methodist Phys. Clinic - Omaha, Nebraska, United States
- Palm Research Center Inc-Vegas - Las Vegas, Nevada, United States
- Central New York Clinical Research CNYCR - Manlius, New York, United States
Showing 60 of 330 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →