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

Conditions

• Cardiovascular Risk
• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zenagamtide — DRUG
  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 — DRUG
  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 Details

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.

Key Dates

First listed

Sep 1, 2026

Start date

Aug 24, 2026

Status verified

Aug 2026

Primary completion

Jul 31, 2028

Completion

Sep 20, 2028

Study Design

Enrollment

1,778 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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 Outcome Measure

Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c) [ Time Frame: From baseline (week 0) to week 52 ]

Central Contacts

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (109)

Find similar trials in Birmingham, AL

Related Studies

• The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults
  Recruiting · AdventHealth Translational Research Institute · Orlando, Florida
• Sleep and Glycemic Control in Type 2 Diabetes Adolescents
  Recruiting · Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
• Mechanisms of Fatigability With Diabetes
  Recruiting · University of Michigan · Ann Arbor, Michigan
• Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes
  Recruiting · University of Colorado, Denver · Aurora, Colorado