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Zenagamtide for Obesity and Cardiovascular Risk

(AMBIENCE Trial)

Not yet recruiting at 767 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?

This clinical study is being conducted to evaluate the safety and effectiveness of zenagamtide in people with atherosclerotic cardiovascular disease (ASCVD) and excess body weight compared with placebo. The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have ASCVD and excess body weight. Participants will be randomly assigned by chance to receive either zenagamtide, the investigational treatment being tested, or a placebo, which contains no active medicine. Half of the participants will receive zenagamtide, and treatment assignment will be determined randomly. Zenagamtide is a new investigational medicine that is not yet available for prescription by doctors.

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 who have atherosclerotic cardiovascular disease (such as heart attack, stroke, or blocked arteries) and are overweight or obese. Participants should be generally stable in their health and able to follow study procedures.

Inclusion Criteria

I have had a stroke in the past.
I have lost part of my leg above the ankle due to artery disease.
My Type 2 Diabetes treatment has been stable for at least 90 days.
See 3 more

Exclusion Criteria

Known history of hypoglycaemia unawareness as indicated by Clarke's questionnaire question 8
I have a history of type 1 diabetes.
Glycated haemoglobin (HbA1c) greater than 10% (86 mmol/mol) as measured by central laboratory at screening
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • Zenagamtide

Trial Overview

The study compares zenagamtide, a new investigational medicine, with a placebo (inactive treatment) to see if it safely helps people with ASCVD and excess weight. Participants are randomly assigned to one of the two groups.

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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