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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

RecruitingPhase 3

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

Ages 45 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Novo Nordisk A/S · Participants: 1,778 · Started: Aug 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07797335

Locations in the U.S.

AlabamaUniv of Alabama Birmingham, Birmingham (Not yet recruiting)
Eastern Shore Rsrch Inst, LLC, Fairhope
Chambliss Clinical Trials, LLC, Montgomery
ArizonaHonor Health, Scottsdale (Not yet recruiting)
CaliforniaFirst Valley Medical Group, Lancaster
Headlands Research CTR Lincoln, Lincoln
Torrance Clin Res Inst, Inc., Lomita
Pacific Clinical Studies, Los Alamitos
VAGLAHS Clinical Research Center (CRC), Los Angeles (Not yet recruiting)
Valley Clinical Trials, Inc., Northridge
Paradigm Clinical Research, San Diego
N America Res Inst - San Dimas, San Dimas
Encompass Clinical Research_Spring Valley, Spring Valley
FloridaInnovative Research of W FL, Clearwater
Nature Coast Clin Rsrch_Crystal River, Crystal River (Not yet recruiting)
Florida Premier Cardiology, Delray Beach (Not yet recruiting)
Encore Medical Research LLC, Hollywood
East Coast Institute For Research, Jacksonville (Not yet recruiting)
Jacksonville Ctr for Clin Res, Jacksonville (Not yet recruiting)
Clinical Research of Cent FL, Lakeland
Flourish Research - North Miami, Miami (Not yet recruiting)
Life Spring Research Foundation LLC, Miami
Optimus U, Corp, Miami (Not yet recruiting)
Inpatient Research Clinic LLC, Miami Lakes (Not yet recruiting)
San Marcus Res Clin Miami Lakes, Miami Lakes
Trujillo Medical Centers, Miramar
Suncoast Clinical Research, Inc., New Port Richey (Not yet recruiting)
Ocala Cardiovascular Research, Ocala
Suncoast Clinical Research, Inc., Palm Harbor (Not yet recruiting)
Suncoast Research Associates LLC, Pembroke Pines (Not yet recruiting)
St Johns Center for Clin. Res, Saint Augustine
GeorgiaJavara/Privia Med Grp GA,LLC, Albany
David Kavtaradze MD, Inc., Cordele (Not yet recruiting)
Atlanta Heart Specialist, Tucker (Not yet recruiting)
IdahoRocky Mountain Diab&Osteo Ctr, Idaho Falls
IllinoisElevate Clinical Research, Gurnee
Chicago Medical Research LLC, Hazel Crest
Genesis Orthopedics & Sports Medicine, Oak Brook (Not yet recruiting)
Methodist Medical Center of Illinois, Peoria (Not yet recruiting)
IndianaAmerican Health Network of IN LLC_Franklin, Franklin (Not yet recruiting)
American Health Network of Indiana, LLC_Greenfield, Greenfield (Not yet recruiting)
American Health Network of IN LLC, Muncie (Not yet recruiting)
IowaWest Broadway Clinic, Council Bluffs
University of Iowa Prev Inter Ctr, Iowa City (Not yet recruiting)
Iowa Diab & Endo Res Center, West Des Moines (Not yet recruiting)
KansasCotton O'Neil Diab & Endo Ctr, Topeka
KentuckyThe Research Group of Lexington LLC, Lexington
LouisianaLouisiana Heart Center, Covington (Not yet recruiting)
MarylandAscension Saint Agnes Heart Ca, Baltimore (Not yet recruiting)
MedStar Good Samaritan Hosp, Baltimore (Not yet recruiting)
MassachusettsBrigham & Women's Hospital, Boston (Not yet recruiting)
MichiganHenry Ford Health System, Detroit (Not yet recruiting)
Elite Research Center, Flint
Arcturus Healthcare, PLC., Troy
Trinity Health Michigan Heart, Ypsilanti (Not yet recruiting)
MissouriJohnson County ClinTrials, Kansas City (Not yet recruiting)
Amicis Centers of Clinical Research, St Louis
NebraskaMethodist Phys. Clinic, Omaha
NevadaPalm Research Center Inc-Vegas, Las Vegas (Not yet recruiting)
New YorkCentral New York Clinical Research CNYCR, Manlius (Not yet recruiting)
Mid Hudson Med Res-New Windsor, New Windsor
Harlem Cardiology_Madison ave, New York (Not yet recruiting)
NYC Health + Hospitals/Lincoln, The Bronx (Not yet recruiting)
Prime Global Research Inc., The Bronx
Southgate Medical Group, LLP, West Seneca (Not yet recruiting)
North CarolinaCarteret Medical Group, Morehead City
Piedmont Healthcare/Research, Statesville
Accellacare, Winston-Salem
OhioUniv of Cincinnati Med Cent, Cincinnati (Not yet recruiting)
Advanced Med Res Maumee, Maumee
OklahomaLynn Institute of Norman, Norman
PennsylvaniaHeritage Valley Medical Group, Beaver (Not yet recruiting)
Capital Area Research LLC, Newport
South CarolinaPiedmont Research Partners, LLC, Fort Mill
Accellacare US Inc._SC, Mt. Pleasant (Not yet recruiting)
Trial Management Associates, Myrtle Beach
TennesseeHolston Medical Group Pc, Bristol
The Alliance for Multispecialty Research LLC AMR, Knoxville (Not yet recruiting)
MidState Endocrine Associates, Nashville
TexasPharmaTex Research, Amarillo (Not yet recruiting)
Pinnacle Clinical Research, Austin (Not yet recruiting)
Javara Inc. / Privia Medical Group Gulf Coast PLLC, Conroe
Osvaldo A. Brusco MD, Corpus Christi (Not yet recruiting)
Baylor Jack and Jane Hamilton, Dallas (Not yet recruiting)
Thyroid Endocrinology & Diabetes PA, Dallas
Diabetes and Thyroid Ctr of FW, Fort Worth (Not yet recruiting)
Biopharma Informatic_Houston, Houston
Endocrine And Psychiatry Center, Houston (Not yet recruiting)
JCCT- Juno NW Houston, Houston
Northwest Houston Cardiology, P.A., Houston
PrimeCare Medical Group, Houston
Prem Internal Med Asso Houston, Katy
DCOL Ctr for Clin Res, Longview
Texas Inst, Kdny & Endo Disor, Lufkin
PRX Research, Mesquite (Not yet recruiting)
Clinical Advancement Center, San Antonio
NE Clin Res of San Antonio, San Antonio
The IMA Group IMA Clinical Trials of America Inc. CTA, San Antonio (Not yet recruiting)
Univ Of Texas Hlth Science Cntr, San Antonio (Not yet recruiting)
VIP Trials, San Antonio
Simcare Medical Research, LLC, Sugar Land
Valley Diab. & Endo Comp Ctr, Weslaco (Not yet recruiting)
UtahProgressive Clinical Research UT, Bountiful (Not yet recruiting)
Alpine Research Association, Layton
Wasatch Clinical Research, LLC, Salt Lake City (Not yet recruiting)
VirginiaCarient Heart and Vascular, Manassas (Not yet recruiting)
Dominion Medical Associates, Richmond (Not yet recruiting)
VA Medical Center_Salem, Salem (Not yet recruiting)
Selma Medical Associates, Winchester

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.