🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07797335
Recruiting Phase 3

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

NCT07797335 · tracked via the Priya Life Science China tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-08-24
Last updated
2026-09-01

Condition(s) studied

Type 2 DiabetesCardiovascular Risk

Investigational drug(s) / intervention(s)

Zenagamtide →Insulin glargine U-100

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).

Study 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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (330)

FacilityCityRegionStatus
Univ of Alabama Birmingham Birmingham Alabama Not Yet Recruiting
Eastern Shore Rsrch Inst, LLC Fairhope Alabama Recruiting
Chambliss Clinical Trials, LLC Montgomery Alabama Recruiting
Honor Health Scottsdale Arizona Not Yet Recruiting
First Valley Medical Group Lancaster California Recruiting
Headlands Research CTR Lincoln Lincoln California Recruiting
Torrance Clin Res Inst, Inc. Lomita California Recruiting
Pacific Clinical Studies Los Alamitos California Recruiting
VAGLAHS Clinical Research Center (CRC) Los Angeles California Not Yet Recruiting
Valley Clinical Trials, Inc. Northridge California Recruiting
Paradigm Clinical Research San Diego California Recruiting
N America Res Inst - San Dimas San Dimas California Recruiting
Encompass Clinical Research_Spring Valley Spring Valley California Recruiting
Innovative Research of W FL Clearwater Florida Recruiting
Nature Coast Clin Rsrch_Crystal River Crystal River Florida Not Yet Recruiting
Florida Premier Cardiology Delray Beach Florida Not Yet Recruiting
Encore Medical Research LLC Hollywood Florida Recruiting
East Coast Institute For Research Jacksonville Florida Not Yet Recruiting
Jacksonville Ctr for Clin Res Jacksonville Florida Not Yet Recruiting
Clinical Research of Cent FL Lakeland Florida Recruiting
Life Spring Research Foundation LLC Miami Florida Recruiting
Optimus U, Corp Miami Florida Not Yet Recruiting
Flourish Research - North Miami Miami Florida Not Yet Recruiting
Inpatient Research Clinic LLC Miami Lakes Florida Not Yet Recruiting
San Marcus Res Clin Miami Lakes Miami Lakes Florida Recruiting
Trujillo Medical Centers Miramar Florida Recruiting
Suncoast Clinical Research, Inc. New Port Richey Florida Not Yet Recruiting
Ocala Cardiovascular Research Ocala Florida Recruiting
Suncoast Clinical Research, Inc. Palm Harbor Florida Not Yet Recruiting
Suncoast Research Associates LLC Pembroke Pines Florida Not Yet Recruiting
St Johns Center for Clin. Res Saint Augustine Florida Recruiting
Javara/Privia Med Grp GA,LLC Albany Georgia Recruiting
David Kavtaradze MD, Inc. Cordele Georgia Not Yet Recruiting
Atlanta Heart Specialist Tucker Georgia Not Yet Recruiting
Rocky Mountain Diab&Osteo Ctr Idaho Falls Idaho Recruiting
Elevate Clinical Research Gurnee Illinois Recruiting
Chicago Medical Research LLC Hazel Crest Illinois Recruiting
Genesis Orthopedics & Sports Medicine Oak Brook Illinois Not Yet Recruiting
Methodist Medical Center of Illinois Peoria Illinois Not Yet Recruiting
American Health Network of IN LLC_Franklin Franklin Indiana Not Yet Recruiting

+ 290 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07797335 on ClinicalTrials.gov ↗ ← All trials in China