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Zenagamtide for Type 2 Diabetes

(AMBITION 2 Trial)

Not yet recruiting at 124 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 and chronic kidney disease. 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 placebo. 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 and chronic kidney disease who are currently taking daily basal insulin, either alone or with metformin, SGLT2 inhibitors, or both. Participants should be generally stable on their current medications.

Inclusion Criteria

I have a history of chronic kidney disease.
My basal insulin dose has stayed within 20% of the same amount recently.
I am 18 years old or older.
See 4 more

Exclusion Criteria

I am pregnant, breastfeeding, or not using birth control if I could become pregnant.
I have not used diabetes or obesity drugs, except short-term insulin or for pregnancy.
I have used GLP-1 or similar diabetes medications before joining this study.
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Zenagamtide

Trial Overview

The study compares a new drug called zenagamtide to a placebo in people with type 2 diabetes and chronic kidney disease. Participants are randomly assigned to receive either zenagamtide or placebo along with their usual treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ZenagamtideExperimental Treatment1 Intervention
Group II: 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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