NNC0487-0111 for Obesity

(AMAZE 1 Trial)

Not yet recruiting at 71 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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 NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This study is for men and women with excess body weight who have tried to lose weight through dieting without success. Participants must give informed consent and be willing to receive weekly injections. People are excluded if they don't meet these criteria or have conditions that could interfere with the study.

Inclusion Criteria

* Male or female (sex at birth).

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

* History of at least one self-reported unsuccessful dietary effort to lose body weight.

What Are the Treatments Tested in This Trial?

Interventions

• NNC0487-0111

Trial Overview

The trial is testing NNC0487-0111, a new medicine given as a weekly injection under the skin, against a placebo (a substance with no active medication). The assignment of either NNC0487-0111 or placebo to participants is random.

How Is the Trial Designed?

Group I: NNC0487-0111 Experimental Treatment 1 Intervention

Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen