Recruiting

Phase 3

Zenagamtide vs. Insulin GlargineAMBITION 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

Code:

NCT07797335

Conditions

Type 2 Diabetes

Cardiovascular Risk

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Zenagamtide

Insulin glargine U-100

Study Details

Brief 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.

Conditions

Type 2 Diabetes

Cardiovascular Risk

Study ID

NCT07797335

Start date

Aug 24, 2026

Status verified date

Aug, 2026

Completion date

Sep 20, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1778 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zenagamtide

Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.

active comparator: Insulin glargine U-100

Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.

Interventions

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).

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).

Primary outcome measure

Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c) [ Time Frame: From baseline (week 0) to week 52 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations

Eastern Shore Rsrch Inst, LLC

Recruiting

Fairhope, Alabama, United States, 36532

Chambliss Clinical Trials, LLC

Recruiting

Montgomery, Alabama, United States, 36106

First Valley Medical Group

Recruiting

Lancaster, California, United States, 93534

Headlands Research CTR Lincoln

Recruiting

Lincoln, California, United States, 95648

Torrance Clin Res Inst, Inc.

Recruiting

Lomita, California, United States, 90717

Pacific Clinical Studies

Recruiting

Los Alamitos, California, United States, 90720

Valley Clinical Trials, Inc.

Recruiting

Northridge, California, United States, 91325

Paradigm Clinical Research

Recruiting

San Diego, California, United States, 92108

N America Res Inst - San Dimas

Recruiting

San Dimas, California, United States, 91773

Encompass Clinical Research_Spring Valley

Recruiting

Spring Valley, California, United States, 91978

Innovative Research of W FL

Recruiting

Clearwater, Florida, United States, 33756

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

Clinical Research of Cent FL

Recruiting

Lakeland, Florida, United States, 33805

Life Spring Research Foundation LLC

Recruiting

Miami, Florida, United States, 33130

San Marcus Res Clin Miami Lakes

Recruiting

Miami Lakes, Florida, United States, 33014

Trujillo Medical Centers

Recruiting

Miramar, Florida, United States, 33027

Ocala Cardiovascular Research

Recruiting

Ocala, Florida, United States, 34471

St Johns Center for Clin. Res

Recruiting

Saint Augustine, Florida, United States, 32086

Javara/Privia Med Grp GA,LLC

Recruiting

Albany, Georgia, United States, 31707

Rocky Mountain Diab&Osteo Ctr

Recruiting

Idaho Falls, Idaho, United States, 83404

Elevate Clinical Research

Recruiting

Gurnee, Illinois, United States, 60031

Chicago Medical Research LLC

Recruiting

Hazel Crest, Illinois, United States, 60429

West Broadway Clinic

Recruiting

Council Bluffs, Iowa, United States, 51501

Cotton O'Neil Diab & Endo Ctr

Recruiting

Topeka, Kansas, United States, 66606

The Research Group of Lexington LLC

Recruiting

Lexington, Kentucky, United States, 40503

Elite Research Center

Recruiting

Flint, Michigan, United States, 48532

Arcturus Healthcare, PLC.

Recruiting

Troy, Michigan, United States, 48098

Amicis Centers of Clinical Research

Recruiting

St Louis, Missouri, United States, 63128

Methodist Phys. Clinic

Recruiting

Omaha, Nebraska, United States, 68114

Mid Hudson Med Res-New Windsor

Recruiting

New Windsor, New York, United States, 12553

Prime Global Research Inc.

Recruiting

The Bronx, New York, United States, 10456

Carteret Medical Group

Recruiting

Morehead City, North Carolina, United States, 28557

Piedmont Healthcare/Research

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare

Recruiting

Winston-Salem, North Carolina, United States, 27103

Advanced Med Res Maumee

Recruiting

Maumee, Ohio, United States, 43537

Lynn Institute of Norman

Recruiting

Norman, Oklahoma, United States, 73072

Capital Area Research LLC

Recruiting

Newport, Pennsylvania, United States, 17074

Piedmont Research Partners, LLC

Recruiting

Fort Mill, South Carolina, United States, 29707

Trial Management Associates

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Holston Medical Group Pc

Recruiting

Bristol, Tennessee, United States, 37620-7352

MidState Endocrine Associates

Recruiting

Nashville, Tennessee, United States, 37203

Javara Inc. / Privia Medical Group Gulf Coast PLLC

Recruiting

Conroe, Texas, United States, 77384

Thyroid Endocrinology & Diabetes PA

Recruiting

Dallas, Texas, United States, 75208

PrimeCare Medical Group

Recruiting

Houston, Texas, United States, 77024

JCCT- Juno NW Houston

Recruiting

Houston, Texas, United States, 77040

Biopharma Informatic_Houston

Recruiting

Houston, Texas, United States, 77043

Northwest Houston Cardiology, P.A.

Recruiting

Houston, Texas, United States, 77070

Prem Internal Med Asso Houston

Recruiting

Katy, Texas, United States, 77493

DCOL Ctr for Clin Res

Recruiting

Longview, Texas, United States, 75605

Texas Inst, Kdny & Endo Disor

Recruiting

Lufkin, Texas, United States, 75904

Clinical Advancement Center

Recruiting

San Antonio, Texas, United States, 78212

VIP Trials

Recruiting

San Antonio, Texas, United States, 78230

NE Clin Res of San Antonio

Recruiting

San Antonio, Texas, United States, 78233

Simcare Medical Research, LLC

Recruiting

Sugar Land, Texas, United States, 77478

Alpine Research Association

Recruiting

Layton, Utah, United States, 84041

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601-3834

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.