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
Purpose
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
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama 36532
Fairhope, Alabama 36532
Chambliss Clinical Trials, LLC
Montgomery, Alabama 36106
Montgomery, Alabama 36106
First Valley Medical Group
Lancaster, California 93534
Lancaster, California 93534
Headlands Research CTR Lincoln
Lincoln, California 95648
Lincoln, California 95648
Torrance Clin Res Inst, Inc.
Lomita, California 90717
Lomita, California 90717
Pacific Clinical Studies
Los Alamitos, California 90720
Los Alamitos, California 90720
Valley Clinical Trials, Inc.
Northridge, California 91325
Northridge, California 91325
Paradigm Clinical Research
San Diego, California 92108
San Diego, California 92108
N America Res Inst - San Dimas
San Dimas, California 91773
San Dimas, California 91773
Encompass Clinical Research_Spring Valley
Spring Valley, California 91978
Spring Valley, California 91978
Innovative Research of W FL
Clearwater, Florida 33756
Clearwater, Florida 33756
Encore Medical Research LLC
Hollywood, Florida 33024
Hollywood, Florida 33024
Clinical Research of Cent FL
Lakeland, Florida 33805
Lakeland, Florida 33805
Life Spring Research Foundation LLC
Miami, Florida 33130
Miami, Florida 33130
San Marcus Res Clin Miami Lakes
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Trujillo Medical Centers
Miramar, Florida 33027
Miramar, Florida 33027
Ocala Cardiovascular Research
Ocala, Florida 34471
Ocala, Florida 34471
St Johns Center for Clin. Res
Saint Augustine, Florida 32086
Saint Augustine, Florida 32086
Javara/Privia Med Grp GA,LLC
Albany, Georgia 31707
Albany, Georgia 31707
Rocky Mountain Diab&Osteo Ctr
Idaho Falls, Idaho 83404
Idaho Falls, Idaho 83404
Elevate Clinical Research
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Chicago Medical Research LLC
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
West Broadway Clinic
Council Bluffs, Iowa 51501
Council Bluffs, Iowa 51501
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas 66606
Topeka, Kansas 66606
The Research Group of Lexington LLC
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Elite Research Center
Flint, Michigan 48532
Flint, Michigan 48532
Arcturus Healthcare, PLC.
Troy, Michigan 48098
Troy, Michigan 48098
Amicis Centers of Clinical Research
St Louis, Missouri 63128
St Louis, Missouri 63128
Methodist Phys. Clinic
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Mid Hudson Med Res-New Windsor
New Windsor, New York 12553
New Windsor, New York 12553
Prime Global Research Inc.
The Bronx, New York 10456
The Bronx, New York 10456
Carteret Medical Group
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Piedmont Healthcare/Research
Statesville, North Carolina 28625
Statesville, North Carolina 28625
Accellacare
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Advanced Med Res Maumee
Maumee, Ohio 43537
Maumee, Ohio 43537
Lynn Institute of Norman
Norman, Oklahoma 73072
Norman, Oklahoma 73072
Capital Area Research LLC
Newport, Pennsylvania 17074
Newport, Pennsylvania 17074
Piedmont Research Partners, LLC
Fort Mill, South Carolina 29707
Fort Mill, South Carolina 29707
Trial Management Associates
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Holston Medical Group Pc
Bristol, Tennessee 37620-7352
Bristol, Tennessee 37620-7352
MidState Endocrine Associates
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Javara Inc. / Privia Medical Group Gulf Coast PLLC
Conroe, Texas 77384
Conroe, Texas 77384
Thyroid Endocrinology & Diabetes PA
Dallas, Texas 75208
Dallas, Texas 75208
PrimeCare Medical Group
Houston, Texas 77024
Houston, Texas 77024
JCCT- Juno NW Houston
Houston, Texas 77040
Houston, Texas 77040
Biopharma Informatic_Houston
Houston, Texas 77043
Houston, Texas 77043
Northwest Houston Cardiology, P.A.
Houston, Texas 77070
Houston, Texas 77070
Prem Internal Med Asso Houston
Katy, Texas 77493
Katy, Texas 77493
DCOL Ctr for Clin Res
Longview, Texas 75605
Longview, Texas 75605
Texas Inst, Kdny & Endo Disor
Lufkin, Texas 75904
Lufkin, Texas 75904
Clinical Advancement Center
San Antonio, Texas 78212
San Antonio, Texas 78212
VIP Trials
San Antonio, Texas 78230
San Antonio, Texas 78230
NE Clin Res of San Antonio
San Antonio, Texas 78233
San Antonio, Texas 78233
Simcare Medical Research, LLC
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Alpine Research Association
Layton, Utah 84041
Layton, Utah 84041
Selma Medical Associates
Winchester, Virginia 22601-3834
Winchester, Virginia 22601-3834
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S