Zenagamtide for Obesity

(AMAZE 9 Trial)

Not yet recruiting at 41 trial locations
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 excess body weight. There are 2 study treatments in this study taken as oral tablets once a day. Participants will either get zenagamtide (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

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 aged 18 and older who have excess body weight. People with diabetes or those already taking certain weight-loss medications (like GLP-1, GIP receptor agonists, or amylin analogues) cannot participate.

Inclusion Criteria

I am 18 years old or older.
My sex at birth is male or female.

Exclusion Criteria

Glycated haemoglobin (HbA1c) ≥ 6.5% [48 mmol/mol] as measured by the central laboratory at screening
I have been diagnosed with diabetes (type 1 or type 2).
I have taken GLP-1, dual GLP-1/GIP drugs, or amylin analogues before joining this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zenagamtide or placebo orally once daily as an adjunct to a reduced-calorie diet and increased physical activity

76 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Zenagamtide

Trial Overview

The study tests whether zenagamtide tablets help people lose weight compared to a placebo tablet with no active medicine. Participants are randomly assigned to one of the two groups and take their assigned tablet once daily.

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