RecruitingPHASE3INTERVENTIONAL

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

This research study, called AMBITION 7, is designed to test a new medicine called zenagamtide. It's for adults aged 45 and over who have type 2 diabetes and are also at a higher risk of heart attacks, strokes, or other blood vessel issues. Participants will already be taking one to three other diabetes medications. The study compares zenagamtide with insulin glargine, which is a common type of insulin. Both are given as injections under the skin once a week. The main goal is to find out how well zenagamtide works to lower blood sugar and body weight, and to check its safety, compared to insulin glargine. Participants will be randomly chosen to receive one of the two treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

1,778

Start

24 Aug 2026

Estimated completion

20 Sep 2028

Type 2 Diabetes Cardiovascular Risk

What is this study about?

This clinical trial is named AMBITION 7 and it's looking into a new treatment for type 2 diabetes called zenagamtide. It's designed for people who have type 2 diabetes and are also considered to be at a higher risk of developing problems with their heart and blood vessels, like heart attacks or strokes. Participants in this study will already be taking one to three other medications for their diabetes.

The main purpose of the study is to see how well zenagamtide works and how safe it is, especially when compared to a commonly used insulin called insulin glargine. Both of these treatments are given as injections under the skin once a week. Researchers will be carefully checking how zenagamtide affects blood sugar levels and body weight, as well as looking at any side effects.

By comparing zenagamtide to an existing treatment, the study aims to understand if this new drug could be a valuable option for managing type 2 diabetes, particularly for those with heart and blood vessel risks. Finding effective and safe ways to manage diabetes is very important, and studies like this help improve future treatment options for patients.

Key takeaways

Tests a new diabetes drug (zenagamtide) against standard insulin (glargine).
For people with type 2 diabetes and higher risk of heart/blood vessel problems.
Participants continue taking 1-3 other diabetes medicines.
Treatments are weekly injections, assigned by chance.
Aims to check effects on blood sugar, body weight, and safety.
Close medical monitoring if you participate.

Who may be eligible?

To be considered for this study, you need to meet certain conditions. You must be at least 45 years old and have had a diagnosis of type 2 diabetes for at least six months. You should also be currently taking between one and three other regular medications for your diabetes, which you've been taking at a steady dose for a while.

A key part of joining this study is that you must have a higher risk of heart or blood vessel problems. This could mean you've had a heart attack or stroke before, or have been diagnosed with certain heart conditions, kidney problems, or circulation issues in your legs.

Before you can start, you'll need to understand and agree to take part by signing a consent form. This makes sure you know exactly what the study involves. The study team will check all these details to see if this trial is the right fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 45 or older?
Have you had type 2 diabetes for at least 6 months?
Are you currently taking 1 to 3 regular diabetes medications?
Do you have a higher risk of heart attack, stroke, or other blood vessel problems (e.g., previous heart attack, stroke, or certain heart/kidney conditions)?
Are you willing to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be assigned either zenagamtide (the new medicine) or insulin glargine (a common insulin) by chance, like flipping a coin. Both are given as injections under the skin once a week. You'll have regular visits to the clinic where the study team will monitor your health, check your blood sugar, and look for any side effects.

These visits will include various tests, such as blood tests, to see how your body is responding to the treatment. The total duration of your participation in the study, including all visits and follow-up, will be explained in detail by the study team. You'll be given all the study medication you need.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of joining this study is that you would receive close medical attention and regular health monitoring from a dedicated research team. You might also gain access to a new diabetes medication, zenagamtide, before it's widely available. However, there's no guarantee that the treatment will help your specific condition, and you might receive the comparator medicine. Potential risks could include side effects from the medications, such as reactions at the injection site or changes in blood sugar levels, or the inconvenience of study visits and tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (330)

Univ of Alabama Birmingham
Verified postcode
Birmingham, United States· Not yet recruiting
Eastern Shore Rsrch Inst, LLC
Verified postcode
Fairhope, United States· Recruiting
Chambliss Clinical Trials, LLC
Verified postcode
Montgomery, United States· Recruiting
Honor Health
Verified postcode
Scottsdale, United States· Not yet recruiting
First Valley Medical Group
Verified postcode
Lancaster, United States· Recruiting
Headlands Research CTR Lincoln
Verified postcode
Lincoln, United States· Recruiting
Torrance Clin Res Inst, Inc.
Verified postcode
Lomita, United States· Recruiting
Pacific Clinical Studies
Verified postcode
Los Alamitos, United States· Recruiting
VAGLAHS Clinical Research Center (CRC)
Verified postcode
Los Angeles, United States· Not yet recruiting
Valley Clinical Trials, Inc.
Verified postcode
Northridge, United States· Recruiting
Paradigm Clinical Research
Verified postcode
San Diego, United States· Recruiting
N America Res Inst - San Dimas
Verified postcode
San Dimas, United States· Recruiting

Common questions

What is zenagamtide?

Zenagamtide is a new medication being tested to see how well it helps people with type 2 diabetes control their blood sugar and body weight.

How will I know if I get the new drug or the old one?

You will be assigned one of the two treatments (zenagamtide or insulin glargine) by chance. Neither you nor the study doctors will know which one you are receiving during the main part of the study.

Do I have to stop my current diabetes medicines?

No, you will continue to take your current 1 to 3 diabetes medications as part of this study, alongside the study treatment.

What kind of heart and blood vessel problems put me at higher risk?

This could include having had a heart attack or stroke, certain heart or kidney conditions, or issues with circulation in your legs, as determined by the study doctors.

How long will the study last if I join?

The total length of time you'd be involved in the study, including all visits and follow-ups, will be explained in detail by the research team if you are eligible.

How to find out more

Novo Nordisk

clinicaltrials@novonordisk.com (+1) 866-867-7178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.