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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Injections
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "There are 2 study treatments in this study taken as injections under the skin once a week."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares zenagamtide with insulin glargine to see how well they lower blood sugar and body weight and how safe they are. It is for adults age 45 or older with type 2 diabetes, a higher risk of heart and blood vessel problems, and treatment with 1–3 diabetes medicines. The study treatment is chosen by chance.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Agree to join before any study tests or procedures.
- Be age 45 or older. People of all gender identities may join.
- Have had type 2 diabetes for at least 180 days before screening.
- Take 1–3 allowed diabetes medicines by mouth, with no changes in the medicines or daily doses before screening.
- Have an HbA1c blood test, which measures average blood sugar. The listing does not state the required level.
- Have a higher risk of heart or blood vessel problems because of at least one listed condition: a past heart attack or stroke, documented heart artery disease, long-term kidney disease, or leg artery disease with symptoms.
- Heart artery disease must include a listed finding, such as at least 50% narrowing, reduced blood flow on a stress test, past unstable chest pain with heart test changes, or a past procedure to restore heart blood flow.
- Leg artery disease must include walking pain with specified blood flow test results or at least 50% artery narrowing, a past procedure to restore leg blood flow, or an amputation at or above the ankle due to hardened arteries.
Who can't join
- A heart attack, stroke, mini-stroke, or hospital stay for unstable chest pain within 60 days before screening.
- A planned procedure to restore blood flow in heart, neck, or other body arteries.
- Dialysis, a treatment that filters the blood when kidneys cannot, within 90 days before screening.
- Use of diabetes or weight-loss medicines other than those allowed. Exceptions include insulin for diabetes during pregnancy or insulin for no more than 14 days in a row.
- Use before screening of GLP-1 medicines, combined GLP-1/GIP medicines, other GLP-1-based treatments, DPP-4 inhibitors, or amylin-like medicines.
- Diabetes-related eye disease treated with laser, eye surgery, or anti-VEGF medicines within 180 days before screening, or expected to need treatment within 180 days after screening.
- Trouble noticing low blood sugar, or any past diabetic ketoacidosis—a dangerous buildup of acids linked to diabetes.
- Thyroid disease that is not under control, as judged by the study doctor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (109)
AL
- Univ of Alabama Birmingham · Birmingham, AL 35294More trials in Birmingham
- Eastern Shore Rsrch Inst, LLC · Fairhope, AL 36532More trials in Fairhope
- Chambliss Clinical Trials, LLC · Montgomery, AL 36106More trials in Montgomery
AZ
- Honor Health · Scottsdale, AZ 85258More trials in Scottsdale
CA
- First Valley Medical Group · Lancaster, CA 93534More trials in Lancaster
- Headlands Research CTR Lincoln · Lincoln, CA 95648More trials in Lincoln
- Torrance Clin Res Inst, Inc. · Lomita, CA 90717More trials in Lomita
- Pacific Clinical Studies · Los Alamitos, CA 90720More trials in Los Alamitos
- VAGLAHS Clinical Research Center (CRC) · Los Angeles, CA 90073More trials in Los Angeles
- Valley Clinical Trials, Inc. · Northridge, CA 91325More trials in Northridge
- Paradigm Clinical Research · San Diego, CA 92108More trials in San Diego
- N America Res Inst - San Dimas · San Dimas, CA 91773More trials in San Dimas
- Encompass Clinical Research_Spring Valley · Spring Valley, CA 91978More trials in Spring Valley
FL
- Innovative Research of W FL · Clearwater, FL 33756More trials in Clearwater
- Nature Coast Clin Rsrch_Crystal River · Crystal River, FL 34429More trials in Crystal River
- Florida Premier Cardiology · Delray Beach, FL 33484More trials in Delray Beach
- Encore Medical Research LLC · Hollywood, FL 33024More trials in Hollywood
- East Coast Institute For Research · Jacksonville, FL 32216More trials in Jacksonville
- Jacksonville Ctr for Clin Res · Jacksonville, FL 32216More trials in Jacksonville
- Clinical Research of Cent FL · Lakeland, FL 33805More trials in Lakeland
- Life Spring Research Foundation LLC · Miami, FL 33130More trials in Miami
- Optimus U, Corp · Miami, FL 33135More trials in Miami
- Flourish Research - North Miami · Miami, FL 33138More trials in Miami
- Inpatient Research Clinic LLC · Miami Lakes, FL 33014More trials in Miami Lakes
- San Marcus Res Clin Miami Lakes · Miami Lakes, FL 33014More trials in Miami Lakes
- Trujillo Medical Centers · Miramar, FL 33027More trials in Miramar
- Suncoast Clinical Research, Inc. · New Port Richey, FL 34652More trials in New Port Richey
- Ocala Cardiovascular Research · Ocala, FL 34471More trials in Ocala
- Suncoast Clinical Research, Inc. · Palm Harbor, FL 34684More trials in Palm Harbor
- Suncoast Research Associates LLC · Pembroke Pines, FL 33024More trials in Pembroke Pines
- St Johns Center for Clin. Res · Saint Augustine, FL 32086More trials in Saint Augustine
GA
- Javara/Privia Med Grp GA,LLC · Albany, GA 31707More trials in Albany
- David Kavtaradze MD, Inc. · Cordele, GA 31015More trials in Cordele
- Atlanta Heart Specialist · Tucker, GA 30084More trials in Tucker
IA
- West Broadway Clinic · Council Bluffs, IA 51501More trials in Council Bluffs
- University of Iowa Prev Inter Ctr · Iowa City, IA 52772More trials in Iowa City
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ID
- Rocky Mountain Diab&Osteo Ctr · Idaho Falls, ID 83404More trials in Idaho Falls
IL
- Elevate Clinical Research · Gurnee, IL 60031More trials in Gurnee
- Chicago Medical Research LLC · Hazel Crest, IL 60429More trials in Hazel Crest
- Genesis Orthopedics & Sports Medicine · Oak Brook, IL 60523More trials in Oak Brook
- Methodist Medical Center of Illinois · Peoria, IL 61636More trials in Peoria
IN
- American Health Network of IN LLC_Franklin · Franklin, IN 46131More trials in Franklin
- American Health Network of Indiana, LLC_Greenfield · Greenfield, IN 46140More trials in Greenfield
- American Health Network of IN LLC · Muncie, IN 47304More trials in Muncie
KS
- Cotton O'Neil Diab & Endo Ctr · Topeka, KS 66606More trials in Topeka
KY
- The Research Group of Lexington LLC · Lexington, KY 40503More trials in Lexington
LA
- Louisiana Heart Center · Covington, LA 70433More trials in Covington
MA
- Brigham & Women's Hospital · Boston, MA 02115More trials in Boston
MD
- Ascension Saint Agnes Heart Ca · Baltimore, MD 21229More trials in Baltimore
- MedStar Good Samaritan Hosp · Baltimore, MD 21239More trials in Baltimore
MI
- Henry Ford Health System · Detroit, MI 48202More trials in Detroit
- Elite Research Center · Flint, MI 48532More trials in Flint
- Arcturus Healthcare, PLC. · Troy, MI 48098More trials in Troy
- Trinity Health Michigan Heart · Ypsilanti, MI 48197More trials in Ypsilanti
MO
- Johnson County ClinTrials · Kansas City, MO 64112More trials in Kansas City
- Amicis Centers of Clinical Research · St Louis, MO 63128More trials in St Louis
NC
- Carteret Medical Group · Morehead City, NC 28557More trials in Morehead City
- Piedmont Healthcare/Research · Statesville, NC 28625More trials in Statesville
- Accellacare · Winston-Salem, NC 27103More trials in Winston-Salem
NE
- Methodist Phys. Clinic · Omaha, NE 68114More trials in Omaha
NV
- Palm Research Center Inc-Vegas · Las Vegas, NV 89128More trials in Las Vegas
NY
- Central New York Clinical Research CNYCR · Manlius, NY 13104More trials in Manlius
- Mid Hudson Med Res-New Windsor · New Windsor, NY 12553More trials in New Windsor
- Harlem Cardiology_Madison ave · New York, NY 10035More trials in New York
- NYC Health + Hospitals/Lincoln · The Bronx, NY 10451More trials in The Bronx
- Prime Global Research Inc. · The Bronx, NY 10456More trials in The Bronx
- Southgate Medical Group, LLP · West Seneca, NY 14224More trials in West Seneca
OH
- Univ of Cincinnati Med Cent · Cincinnati, OH 45267More trials in Cincinnati
- Advanced Med Res Maumee · Maumee, OH 43537More trials in Maumee
OK
- Lynn Institute of Norman · Norman, OK 73072More trials in Norman
PA
- Heritage Valley Medical Group · Beaver, PA 15009More trials in Beaver
- Capital Area Research LLC · Newport, PA 17074More trials in Newport
SC
- Piedmont Research Partners, LLC · Fort Mill, SC 29707More trials in Fort Mill
- Accellacare US Inc._SC · Mt. Pleasant, SC 29464More trials in Mt. Pleasant
- Trial Management Associates · Myrtle Beach, SC 29572More trials in Myrtle Beach
TN
- Holston Medical Group Pc · Bristol, TN 37620-7352More trials in Bristol
- The Alliance for Multispecialty Research LLC AMR · Knoxville, TN 37909More trials in Knoxville
- MidState Endocrine Associates · Nashville, TN 37203More trials in Nashville
TX
- PharmaTex Research · Amarillo, TX 79106More trials in Amarillo
- Pinnacle Clinical Research · Austin, TX 78757More trials in Austin
- Javara Inc. / Privia Medical Group Gulf Coast PLLC · Conroe, TX 77384More trials in Conroe
- Osvaldo A. Brusco MD · Corpus Christi, TX 78414More trials in Corpus Christi
- Thyroid Endocrinology & Diabetes PA · Dallas, TX 75208More trials in Dallas
- Baylor Jack and Jane Hamilton · Dallas, TX 75226More trials in Dallas
- Diabetes and Thyroid Ctr of FW · Fort Worth, TX 76132More trials in Fort Worth
- PrimeCare Medical Group · Houston, TX 77024More trials in Houston
- JCCT- Juno NW Houston · Houston, TX 77040More trials in Houston
- Biopharma Informatic_Houston · Houston, TX 77043More trials in Houston
- Northwest Houston Cardiology, P.A. · Houston, TX 77070More trials in Houston
- Endocrine And Psychiatry Center · Houston, TX 77095More trials in Houston
- Prem Internal Med Asso Houston · Katy, TX 77493More trials in Katy
- DCOL Ctr for Clin Res · Longview, TX 75605More trials in Longview
- Texas Inst, Kdny & Endo Disor · Lufkin, TX 75904More trials in Lufkin
- PRX Research · Mesquite, TX 75149More trials in Mesquite
- Clinical Advancement Center · San Antonio, TX 78212More trials in San Antonio
- The IMA Group IMA Clinical Trials of America Inc. CTA · San Antonio, TX 78229More trials in San Antonio
- Univ Of Texas Hlth Science Cntr · San Antonio, TX 78229More trials in San Antonio
- VIP Trials · San Antonio, TX 78230More trials in San Antonio
- NE Clin Res of San Antonio · San Antonio, TX 78233More trials in San Antonio
- Simcare Medical Research, LLC · Sugar Land, TX 77478More trials in Sugar Land
- Valley Diab. & Endo Comp Ctr · Weslaco, TX 78596More trials in Weslaco
UT
- Progressive Clinical Research UT · Bountiful, UT 84010More trials in Bountiful
- Alpine Research Association · Layton, UT 84041More trials in Layton
- Wasatch Clinical Research, LLC · Salt Lake City, UT 84107More trials in Salt Lake City
VA
- Carient Heart and Vascular · Manassas, VA 20109More trials in Manassas
- Dominion Medical Associates · Richmond, VA 23219More trials in Richmond
- VA Medical Center_Salem · Salem, VA 24153More trials in Salem
- Selma Medical Associates · Winchester, VA 22601-3834More trials in Winchester