Recruiting

Phase 3

ZenagamtideAMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight

Sponsor:

Novo Nordisk A/S

Code:

NCT07720271

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

zenagamtide

Placebo

Study Details

Brief summary:

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.

Conditions

Overweight

Obesity

Study ID

NCT07720271

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Aug 22, 2028

Anticipated

Primary completion date

Jun 27, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male or female (sex at birth).
Age 18 and older (both inclusive) at time of signing the informed consent.

Exclusion Criteria:

Glycated haemoglobin (HbA1c) more than or equal to (≥) 6.5% \[48 millimoles per mole (mmol/mol)\] as measured by the central laboratory at screening.
History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.

Study Design

Enrollment

950 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: zenagamtide

Participants will be randomized to receive 1 of the 5 dose levels of zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.

placebo comparator: Placebo

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

Interventions

zenagamtide

zenagamtide will be taken orally.

Placebo

Placebo matched to zenagamtide will be taken orally.

Primary outcome measure

Relative change in body weight [ Time Frame: From baseline (week 0) to (week 76) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations

Pinnacle Research Group LLC

Recruiting

Anniston, Alabama, United States, 36207

Univ of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Chambliss Clinical Trials LLC

Recruiting

Montgomery, Alabama, United States, 36106

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Torrance Clinical Research Institute, Inc.

Recruiting

Lomita, California, United States, 90717

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Univ of Colorado at Denver

Recruiting

Aurora, Colorado, United States, 80045

Brain Matters Research

Recruiting

Delray Beach, Florida, United States, 33445

Northeast Research Institute

Recruiting

Fleming Island, Florida, United States, 32003

Miguel Rebollar PA

Recruiting

Hialeah, Florida, United States, 33012

Jacksonville Ctr Clin Res

Recruiting

Jacksonville, Florida, United States, 32216

South Broward Research LLC

Recruiting

Miramar, Florida, United States, 33027

Clinical Neuroscience Solution

Recruiting

Orlando, Florida, United States, 32801

Florida Institute for Clinical Research, LLC

Recruiting

Orlando, Florida, United States, 32825

Oviedo Medical Research, LLC

Recruiting

Oviedo, Florida, United States, 32765

Hope Clin Res & Wellness

Recruiting

Conyers, Georgia, United States, 30094

East West Medical Research Institute_Honolulu

Recruiting

Honolulu, Hawaii, United States, 96814

Great Lakes Clinical Trials

Recruiting

Chicago, Illinois, United States, 60640

Clinical Investigation Spec Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Evanston Premier Hlthcr Res

Recruiting

Skokie, Illinois, United States, 60077

Northern Pines Hlth Ctr, PC

Recruiting

Buckley, Michigan, United States, 49620

StudyMetrix Research LLC

Recruiting

City of Saint Peters, Missouri, United States, 63303

Palm Research Center Inc.

Recruiting

Las Vegas, Nevada, United States, 89128

Comprehensive Weight Ctrl Prog

Recruiting

New York, New York, United States, 10021

Medication Mgmnt, LLC_Grnsboro

Recruiting

Greensboro, North Carolina, United States, 27401

Accellacare of Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Accellacare-Salisbury PMG Res

Recruiting

Salisbury, North Carolina, United States, 28144

Accellacare and KDCILM, LLC

Recruiting

Wilmington, North Carolina, United States, 28401

Lynn Institute of Norman

Recruiting

Norman, Oklahoma, United States, 73072

Clinical Res Collaborative

Recruiting

Cumberland, Rhode Island, United States, 02864

Medical Uni of SC Charleston

Recruiting

Charleston, South Carolina, United States, 29425

Coastal Carolina Research Ctr

Recruiting

North Charleston, South Carolina, United States, 29405

Hillcrest Clinical Research

Recruiting

Simpsonville, South Carolina, United States, 29681-1538

Spartanburg Medical Research

Recruiting

Spartanburg, South Carolina, United States, 29303

Amarillo Medical Specialists

Recruiting

Amarillo, Texas, United States, 79124

North Texas Endocrine Center

Recruiting

Dallas, Texas, United States, 75231

Health Res of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23606

National Clin Res Inc.

Recruiting

Richmond, Virginia, United States, 23294

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.