Taking people in United StatesPhase 3

Zenagamtide versus insulin glargine for type 2 diabetes in people at higher heart risk

Compares zenagamtide with insulin glargine in adults with type 2 diabetes and heart risk.

Plain-language title generated from the registry record
Registry 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

Key facts

Where: Albany, Amarillo, Austin, Baltimore, Beaver, Birmingham, Boston, Bountiful, Bristol, Cincinnati, Clearwater, Conroe, Cordele, Corpus Christi, Council Bluffs, Covington, Crystal River, Dallas, Delray Beach, Detroit, Fairhope, Flint, Fort Mill, Fort Worth, Franklin, Greenfield, Gurnee, Hazel Crest, Hollywood, Houston, Idaho Falls, Iowa City, Jacksonville, Kansas City, Katy, Knoxville, Lakeland, Lancaster, Las Vegas, Layton, Lexington, Lincoln, Lomita, Longview, Los Alamitos, Los Angeles, Lufkin, Manassas, Manlius, Maumee, Mesquite, Miami, Miami Lakes, Miramar, Montgomery, Morehead City, Mt. Pleasant, Muncie, Myrtle Beach, Nashville, New Port Richey, New Windsor, New York, Newport, Norman, Northridge, Oak Brook, Ocala, Omaha, Palm Harbor, Pembroke Pines, Peoria, Richmond, Saint Augustine, Salem, Salt Lake City, San Antonio, San Diego, San Dimas, Scottsdale, Spring Valley, St Louis, Statesville, Sugar Land, The Bronx, Topeka, Troy, Tucker, Weslaco, West Des Moines, West Seneca, Winchester, Winston-Salem, and Ypsilanti, United StatesSee the 109 sites
Phase: Phase 3

Where in United States

Javara/Privia Med Grp GA,LLCAlbany, United StatesTaking people
PharmaTex ResearchAmarillo, United StatesNot yet recruiting
Pinnacle Clinical ResearchAustin, United StatesNot yet recruiting
Ascension Saint Agnes Heart CaBaltimore, United StatesNot yet recruiting
MedStar Good Samaritan HospBaltimore, United StatesNot yet recruiting
Heritage Valley Medical GroupBeaver, United StatesNot yet recruiting
Univ of Alabama BirminghamBirmingham, United StatesNot yet recruiting
Brigham & Women's HospitalBoston, United StatesNot yet recruiting
Progressive Clinical Research UTBountiful, United StatesNot yet recruiting
Holston Medical Group PcBristol, United StatesTaking people
Univ of Cincinnati Med CentCincinnati, United StatesNot yet recruiting
Innovative Research of W FLClearwater, United StatesTaking people
Javara Inc. / Privia Medical Group Gulf Coast PLLCConroe, United StatesTaking people
David Kavtaradze MD, Inc.Cordele, United StatesNot yet recruiting
Osvaldo A. Brusco MDCorpus Christi, United StatesNot yet recruiting
West Broadway ClinicCouncil Bluffs, United StatesTaking people
Louisiana Heart CenterCovington, United StatesNot yet recruiting
Nature Coast Clin Rsrch_Crystal RiverCrystal River, United StatesNot yet recruiting
Baylor Jack and Jane HamiltonDallas, United StatesNot yet recruiting
Thyroid Endocrinology & Diabetes PADallas, United StatesTaking people
Florida Premier CardiologyDelray Beach, United StatesNot yet recruiting
Henry Ford Health SystemDetroit, United StatesNot yet recruiting
Eastern Shore Rsrch Inst, LLCFairhope, United StatesTaking people
Elite Research CenterFlint, United StatesTaking people
Piedmont Research Partners LLCFort Mill, United StatesTaking people
Diabetes and Thyroid Ctr of FWFort Worth, United StatesNot yet recruiting
American Health Network of IN LLC_FranklinFranklin, United StatesNot yet recruiting
American Health Network of Indiana, LLC_GreenfieldGreenfield, United StatesNot yet recruiting
Elevate Clinical ResearchGurnee, United StatesTaking people
Chicago Medical Research LLCHazel Crest, United StatesTaking people
Encore Medical Research LLCHollywood, United StatesTaking people
Biopharma Informatic_HoustonHouston, United StatesTaking people
Endocrine And Psychiatry CenterHouston, United StatesNot yet recruiting
JCCT- Juno NW HoustonHouston, United StatesTaking people
Northwest Houston Cardiology, P.A.Houston, United StatesTaking people
Primecare Medical GroupHouston, United StatesTaking people
Rocky Mountain Diab&Osteo CtrIdaho Falls, United StatesTaking people
University of Iowa Prev Inter CtrIowa City, United StatesNot yet recruiting
East Coast Institute for ResearchJacksonville, United StatesNot yet recruiting
Jacksonville Ctr for Clin ResJacksonville, United StatesNot yet recruiting
Johnson County ClinTrialsKansas City, United StatesNot yet recruiting
Prem Internal Med Asso HoustonKaty, United StatesTaking people
The Alliance for Multispecialty Research LLC (AMR)Knoxville, United StatesNot yet recruiting
Clinical Research of Cent FLLakeland, United StatesTaking people
First Valley Medical GroupLancaster, United StatesTaking people
Palm Research Center Inc-VegasLas Vegas, United StatesNot yet recruiting
Alpine Research AssociationLayton, United StatesTaking people
The Research Group of Lexington LLCLexington, United StatesTaking people
Headlands Research CTR LincolnLincoln, United StatesTaking people
Torrance Clin Res Inst, Inc.Lomita, United StatesTaking people
DCOL Ctr for Clin ResLongview, United StatesTaking people
Pacific Clinical StudiesLos Alamitos, United StatesTaking people
VAGLAHS Clinical Research Center (CRC)Los Angeles, United StatesNot yet recruiting
Texas Inst, Kdny & Endo DisorLufkin, United StatesTaking people
Carient Heart and VascularManassas, United StatesNot yet recruiting
Central New York Clinical Research CNYCRManlius, United StatesNot yet recruiting
Advanced Med Res MaumeeMaumee, United StatesTaking people
PRX ResearchMesquite, United StatesNot yet recruiting
Flourish Research - North MiamiMiami, United StatesNot yet recruiting
Life Spring Research Foundation, LLCMiami, United StatesTaking people
Optimus U CorpMiami, United StatesNot yet recruiting
Inpatient Research Clinic LLCMiami Lakes, United StatesNot yet recruiting
San Marcus Res Clin Miami LakesMiami Lakes, United StatesTaking people
Trujillo Medical CentersMiramar, United StatesTaking people
Chambliss Clinical Trials, LLCMontgomery, United StatesTaking people
Carteret Medical GroupMorehead City, United StatesTaking people
Accellacare US Inc._SCMt. Pleasant, United StatesNot yet recruiting
American Health Network of IN LLCMuncie, United StatesNot yet recruiting
Trial Management AssociatesMyrtle Beach, United StatesTaking people
MidState Endocrine AssociatesNashville, United StatesTaking people
Suncoast Clinical Research, Inc.New Port Richey, United StatesNot yet recruiting
Mid Hudson Med Res-New WindsorNew Windsor, United StatesTaking people
Harlem Cardiology_Madison aveNew York, United StatesNot yet recruiting
Capital Area Research LLCNewport, United StatesTaking people
Lynn Institute of NormanNorman, United StatesTaking people
Valley Clinical Trials, Inc.Northridge, United StatesTaking people
Genesis Orthopedics & Sports MedicineOak Brook, United StatesNot yet recruiting
Ocala Cardiovascular ResearchOcala, United StatesTaking people
Methodist Phys. ClinicOmaha, United StatesTaking people
Suncoast Clinical Research, Inc.Palm Harbor, United StatesNot yet recruiting
Suncoast Research Associates LLCPembroke Pines, United StatesNot yet recruiting
Methodist Medical Center of IllinoisPeoria, United StatesNot yet recruiting
Dominion Medical AssociatesRichmond, United StatesNot yet recruiting
St Johns Center for Clin. ResSaint Augustine, United StatesTaking people
VA Medical Center_SalemSalem, United StatesNot yet recruiting
Wasatch Clinical Research, LLCSalt Lake City, United StatesNot yet recruiting
Clinical Advancement CenterSan Antonio, United StatesTaking people
NE Clin Res of San AntonioSan Antonio, United StatesTaking people
The IMA Group IMA Clinical Trials of America Inc. CTASan Antonio, United StatesNot yet recruiting
Univ Of Texas Hlth Science CntrSan Antonio, United StatesNot yet recruiting
VIP TrialsSan Antonio, United StatesTaking people
Paradigm Clinical ResearchSan Diego, United StatesTaking people
N America Res Inst - San DimasSan Dimas, United StatesTaking people
Honor HealthScottsdale, United StatesNot yet recruiting
Encompass Clinical Research_Spring ValleySpring Valley, United StatesTaking people
Amicis Centers of Clinical ResearchSt Louis, United StatesTaking people
Piedmont Healthcare/ResearchStatesville, United StatesTaking people
Simcare Medical Research, LLCSugar Land, United StatesTaking people
NYC Health + Hospitals/LincolnThe Bronx, United StatesNot yet recruiting
Prime Global Research Inc.The Bronx, United StatesTaking people
Cotton O'Neil Diab & Endo CtrTopeka, United StatesTaking people
Arcturus Healthcare, PLC.Troy, United StatesTaking people
Atlanta Heart SpecialistTucker, United StatesNot yet recruiting
Valley Diab. & Endo Comp CtrWeslaco, United StatesNot yet recruiting
Iowa Diab & Endo Res CenterWest Des Moines, United StatesNot yet recruiting
Southgate Medical Group, LLPWest Seneca, United StatesNot yet recruiting
Selma Medical AssociatesWinchester, United StatesTaking people
AccellacareWinston-Salem, United StatesTaking people
Trinity Health Michigan HeartYpsilanti, United StatesNot yet recruiting

Questions to ask the study team

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Are travel costs paid?
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Trial details

Who runs it: Novo Nordisk A/S
Trial code: NCT07797335
Record updated: 1 September 2026
Original description: 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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening; 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; Uncontrolled thyroid disease as per investigator's discretion; Planned coronary, carotid or peripheral artery revascularisation; Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question; Any episodes of diabetic ketoacidosis before screening.
ClinicalTrials.gov NCT07797335