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Zenagamtide for Type 2 Diabetes

(AMBITION4 Trial)

Not yet recruiting at 151 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 study is testing zenagamtide in participants with type 2 diabetes. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have type 2 diabetes. Participants will either get zenagamtide or semaglutide. Which treatment participants get is decided by chance. Zenagamtide is a new medicine that doctors cannot prescribe yet, but it has been tested in humans before.

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, SGLT2 inhibitors, or both. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

I was diagnosed with type 2 diabetes at least 6 months ago.
I take a stable daily dose of metformin, an SGLT2 inhibitor, or both.
I am 18 years old or older.
See 1 more

Exclusion Criteria

I have diabetic eye disease and recently had or will need eye treatment within 6 months.
I am pregnant, breastfeeding, or not using birth control if I can become pregnant.
I have not had a recent heart attack, stroke, or serious heart issues in the past 60 days.
See 4 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new drug called zenagamtide at low doses to semaglutide at low doses in people with type 2 diabetes. Treatments are assigned randomly and may include placebo versions of each drug.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ZenagamtideExperimental Treatment1 Intervention
Group II: SemaglutideActive Control1 Intervention
Group III: Placebo zenagamtidePlacebo Group1 Intervention
Group IV: Placebo semaglutidePlacebo 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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