Ireland
--:--IST
Starting soon Phase 3

AMBITION 3: A Research Study Investigating How Well Zenagamtide at Higher Dose Levels Lowers Blood Sugar and Body Weight Compared to Semaglutide in People With Type 2 Diabetes Treated With Metformin, SGLT2i, or Both

NCT07931573 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2026-11-10
Last updated
2026-11-12

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Zenagamtide →Semaglutide →Placebo

Zenagamtide: Zenagamtide will be administered subcutaneously

Semaglutide: Semaglutide will be administered subcutaneously

Placebo: Placebo matched to semaglutide or zenagamtide will be administered subcutaneously

Study summary

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will get one of the following: Zenagamtide (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes (T2D) above or equal to 180 days before screening. * On stable daily dose(s) of metformin, sodium-glucose transport 2 (SGLT2) inhibitor, or both (at effective or maximum tolerated dose as judged by the investigator) prior to screening. * Glycated haemoglobin (HbA1c) as determined by central laboratory at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening. * Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening. * Planned coronary, carotid or peripheral artery revascularisation. * 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 GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) 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 within 90 days before screening or in the period between screening and randomisation.

Primary outcome measure(s)

  • Change in glycated haemoglobin (HbA1c) [non-inferiority] — From baseline (week 0) to week 60
    Measured in percentage point

Trial sites (230)

FacilityCityRegionStatus
Rio Clinical Trials Arizona Phoenix Arizona
Scripps Whittier Diabetes Inst La Jolla California
Diabetes & Endocrine Specialists - La Mesa La Mesa California
First Valley Med Grp Lancaster Lancaster California
Los Angeles Institute for Metabolic Research Los Angeles California
Valley Clinical Trials, Inc. Northridge California
Desert Oasis Hlthcr Med Group Palm Springs California
Linda Vista Health Care Ctr San Diego California
Southern Cal Clinical Research Santa Ana California
Encompass Clinical Research_Spring Valley Spring Valley California
Diablo Clinical Research, Inc. Walnut Creek California
Chase Medical Research LLC Waterbury Connecticut
Encore Medical Research LLC Hollywood Florida
University of Florida Cardiology Jacksonville Florida
My Preferred Research Miami Florida
New Horizon Research Center Miami Florida
GTL Med & Res Group Miami Florida
Life Medical Research Group Miami Gardens Florida
South Broward Research LLC Miramar Florida
Adult Medicine of Lake County, Inc Mt. Dora Florida
West Orange Endocrinology Ocoee Florida
Florida Institute for Clinical research Orlando Florida
True Blue Clinical Research Tampa Florida
Encore Medical Research of Weston Weston Florida
Solaris Clinical Research Meridian Idaho
Clinical Invest Special_Gurnee Gurnee Illinois
Cotton O'Neil Diab & Endo Ctr Topeka Kansas
MedStar Health Research Institute Olney Maryland
Endo And Metab Cons Rockville Maryland
Brigham & Women's Hospital Boston Massachusetts
Elite Clinical Research Flint Michigan
StudyMetrix Research LLC City of Saint Peters Missouri
Palm Research Center Inc-Vegas Las Vegas Nevada
Southern NH Diabetes and Endo_Nashua Nashua New Hampshire
AMC Community Endocrinology Albany New York
Southgate Medical Group, LLP West Seneca New York
PharmQuest Life Sciences LLC Greensboro North Carolina
Monroe Biomedical Research, LLC Monroe North Carolina
Accellacare Wilmington North Carolina
Diab & Endo Assoc of Stark Co Canton Ohio

+ 190 more sites — see the full list on the official registry below.

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 NCT07931573 on ClinicalTrials.gov ↗ ← All trials in Germany