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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
More Novo Nordisk A/S trials in the UK
Other trials for the same condition
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 the UK