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Zenagamtide for Type 2 Diabetes

(AMBITION 3 Trial)

Not yet recruiting at 229 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are already taking metformin, an SGLT2 inhibitor, or both. Participants should be able to manage weekly injections and meet other health requirements set by the study team.

Inclusion Criteria

My sex assigned at birth is male or female.
Glycated haemoglobin (HbA1c) as determined by central laboratory at screening
I am 18 years old or older.
See 2 more

Exclusion Criteria

I have taken GLP-1, dual GLP-1/GIP drugs, or amylin analogues before joining the study.
I am scheduled for a procedure to restore blood flow in my arteries.
My heart failure is very severe and limits all physical activity.
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide
  • Zenagamtide

Trial Overview

The study compares a new drug called Zenagamtide (at higher doses) to Semaglutide, both given as weekly injections under the skin. A placebo group may also be included. The goal is to see which treatment better lowers blood sugar and body weight.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ZenagamtideExperimental Treatment1 Intervention
Group II: SemaglutideActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

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