Trial · Interventional
RecruitingPhase 3Registry dataAMBITION 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
Short name AMBITION 7
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 1,778 participants (estimated)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
16 countries
United States, Argentina, Brazil, Bulgaria, Canada, China, Czechia, Germany, Greece, India, Italy, Mexico, Poland, Spain, Turkey (Türkiye), United Kingdom
- Start
- 24 Aug 2026
- Primary completion
- 31 Jul 2028 (estimated)
- Completion
- 20 Sept 2028 (estimated)
- First posted
- 1 Sept 2026
- Last update posted
- 1 Sept 2026
- Conditions
- Type 2 Diabetes · Cardiovascular Risk
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ZenagamtideDrug
- Insulin glargine U-100Drug
Arms2
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Time frame · From baseline (week 0) to week 52
Registry description
Measured as percentage (%)-points
Secondary outcomes(9)
Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Time frame · From baseline (week 0) to 104 weeks or more
Registry description
Measured as days
Relative change in body weight
Time frame · From baseline (week 0) to week 52
Registry description
Measured as percentage (%) change
Superiority of zenagamtide versus insulin: Change in HbA1c
Time frame · From baseline (week 0) to week 52
Registry description
Measured as %-points
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Time frame · From baseline (week 0) to 104 weeks or more
Registry description
Measured as Days
Change in waist circumference
Time frame · From baseline (week 0) to week 52
Registry description
Measured as centimeters
Change in systolic blood pressure
Time frame · From baseline (week 0) to week 52
Registry description
Measured as millimeters of mercury (mmHg)
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame · From baseline (week 0) to week 52
Registry description
Measured as ratio to baseline
Change in Triglycerides
Time frame · From baseline (week 0) to week 52
Registry description
Measured as ratio to baseline
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Time frame · From baseline (week 0) to week 52
Registry description
Measured as ratio to baseline
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 45 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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