RecruitingPhase 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

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "There are 2 study treatments in this study taken as injections under the skin once a week."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares zenagamtide with insulin glargine to see how well they lower blood sugar and body weight and how safe they are. It is for adults age 45 or older with type 2 diabetes, a higher risk of heart and blood vessel problems, and treatment with 1–3 diabetes medicines. The study treatment is chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to join before any study tests or procedures.
  • Be age 45 or older. People of all gender identities may join.
  • Have had type 2 diabetes for at least 180 days before screening.
  • Take 1–3 allowed diabetes medicines by mouth, with no changes in the medicines or daily doses before screening.
  • Have an HbA1c blood test, which measures average blood sugar. The listing does not state the required level.
  • Have a higher risk of heart or blood vessel problems because of at least one listed condition: a past heart attack or stroke, documented heart artery disease, long-term kidney disease, or leg artery disease with symptoms.
  • Heart artery disease must include a listed finding, such as at least 50% narrowing, reduced blood flow on a stress test, past unstable chest pain with heart test changes, or a past procedure to restore heart blood flow.
  • Leg artery disease must include walking pain with specified blood flow test results or at least 50% artery narrowing, a past procedure to restore leg blood flow, or an amputation at or above the ankle due to hardened arteries.

Who can't join

  • A heart attack, stroke, mini-stroke, or hospital stay for unstable chest pain within 60 days before screening.
  • A planned procedure to restore blood flow in heart, neck, or other body arteries.
  • Dialysis, a treatment that filters the blood when kidneys cannot, within 90 days before screening.
  • Use of diabetes or weight-loss medicines other than those allowed. Exceptions include insulin for diabetes during pregnancy or insulin for no more than 14 days in a row.
  • Use before screening of GLP-1 medicines, combined GLP-1/GIP medicines, other GLP-1-based treatments, DPP-4 inhibitors, or amylin-like medicines.
  • Diabetes-related eye disease treated with laser, eye surgery, or anti-VEGF medicines within 180 days before screening, or expected to need treatment within 180 days after screening.
  • Trouble noticing low blood sugar, or any past diabetic ketoacidosis—a dangerous buildup of acids linked to diabetes.
  • Thyroid disease that is not under control, as judged by the study doctor.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (109)

AL

AZ

CA

FL

GA

IA

ID

IL

IN

KS

KY

LA

MA

MD

MI

MO

NC

NE

NV

NY

OH

OK

PA

SC

TN

TX

UT

VA