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
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)
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c) — From baseline (week 0) to week 52 Measured as percentage (%)-points
Trial sites (330)
Facility
City
Region
Status
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.
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.
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