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RECRUITING

NCT07797335

PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1778

Start Date

2026-08-24

Completion Date

2028-09-20

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Type 2 Diabetes Cardiovascular Risk

Interventions

DRUG

Zenagamtide

Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).

DRUG

Insulin glargine U-100

Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).

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.

Locations (330)

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

Mid Hudson Med Res-New Windsor

New Windsor, New York, United States

Harlem Cardiology_Madison ave

New York, New York, United States

NYC Health + Hospitals/Lincoln

The Bronx, New York, United States

Prime Global Research Inc.

The Bronx, New York, United States

Southgate Medical Group, LLP

West Seneca, New York, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Piedmont Healthcare/Research

Statesville, North Carolina, United States

Accellacare

Winston-Salem, North Carolina, United States

Univ of Cincinnati Med Cent

Cincinnati, Ohio, United States

Advanced Med Res Maumee

Maumee, Ohio, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

Heritage Valley Medical Group

Beaver, Pennsylvania, United States

Capital Area Research LLC

Newport, Pennsylvania, United States

Piedmont Research Partners, LLC

Fort Mill, South Carolina, United States

Accellacare US Inc._SC

Mt. Pleasant, South Carolina, United States

Trial Management Associates

Myrtle Beach, South Carolina, United States

Holston Medical Group Pc

Bristol, Tennessee, United States

The Alliance for Multispecialty Research LLC AMR

Knoxville, Tennessee, United States

MidState Endocrine Associates

Nashville, Tennessee, United States

PharmaTex Research

Amarillo, Texas, United States

Pinnacle Clinical Research

Austin, Texas, United States

Javara Inc. / Privia Medical Group Gulf Coast PLLC

Conroe, Texas, United States

Osvaldo A. Brusco MD

Corpus Christi, Texas, United States

Thyroid Endocrinology & Diabetes PA

Dallas, Texas, United States

Baylor Jack and Jane Hamilton

Dallas, Texas, United States

Diabetes and Thyroid Ctr of FW

Fort Worth, Texas, United States

PrimeCare Medical Group

Houston, Texas, United States

JCCT- Juno NW Houston

Houston, Texas, United States

Biopharma Informatic_Houston

Houston, Texas, United States

Northwest Houston Cardiology, P.A.

Houston, Texas, United States

Endocrine And Psychiatry Center

Houston, Texas, United States

Prem Internal Med Asso Houston

Katy, Texas, United States

DCOL Ctr for Clin Res

Longview, Texas, United States

Texas Inst, Kdny & Endo Disor

Lufkin, Texas, United States

PRX Research

Mesquite, Texas, United States

Clinical Advancement Center