Recruiting

Phase 3

Zenagamtide vs. SemaglutideA Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide

Sponsor:

Novo Nordisk A/S

Code:

NCT07668414

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zenagamtide

Semaglutide

Placebo (matched to semaglutide)

Placebo (matched to zenagamtide)

Study Details

Brief summary:

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

Conditions

Overweight

Obesity

Study ID

NCT07668414

Start date

Sep 22, 2026

Status verified date

Sep, 2026

Completion date

Oct 10, 2028

Anticipated

Primary completion date

Oct 10, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Male or female (sex at birth).
Age 18 years or above at the time of signing the informed consent.

Exclusion Criteria:

Glycated haemoglobin (HbA1c) ≥ 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 within 1 year before screening.

Study Design

Enrollment

650 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zenagamtide

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

active comparator: Semaglutide dose 1

Participants will receive semaglutide dose 1 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

active comparator: Semaglutide dose 2

Participants will receive semaglutide dose 2 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Interventions

Zenagamtide

Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Semaglutide

Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to semaglutide)

Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to zenagamtide)

Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Primary outcome measure

Relative change in body weight [ Time Frame: From week 0 to week 84 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

First Valley Medical Group

Recruiting

Lancaster, California, United States, 93534

Desert Oasis Healthcare

Recruiting

Palm Springs, California, United States, 92262

Western University of Health Sciences

Recruiting

Pomona, California, United States, 91766

Artemis Insitute for Clin Res

Recruiting

San Diego, California, United States, 92123

Med Home Development Grp

Recruiting

Washington D.C., District of Columbia, United States, 20037

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

NextPhase Research

Recruiting

Hollywood, Florida, United States, 33024

PharmaDev Clinical Research Institute LLC

Recruiting

Miami, Florida, United States, 33176

South Broward Research LLC

Recruiting

Miramar, Florida, United States, 33027

Florida Inst For Clin Res LLC

Recruiting

Orlando, Florida, United States, 32825

Oviedo Medical Research, LLC

Recruiting

Oviedo, Florida, United States, 32765

Palm Beach Research Center

Recruiting

West Palm Beach, Florida, United States, 33409

Encore Medical Research of Weston

Recruiting

Weston, Florida, United States, 33331

Conquest Research

Recruiting

Atlanta, Georgia, United States, 30328

Eastside Bariatric and Gen Surg

Recruiting

Snellville, Georgia, United States, 30078

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Midwest Inst For Clin Res

Recruiting

Indianapolis, Indiana, United States, 46260

Amicis Centers of Clinical Research

Recruiting

St Louis, Missouri, United States, 63128

Ichor Research

Recruiting

Syracuse, New York, United States, 13210

Southgate Medical Group, LLP

Recruiting

West Seneca, New York, United States, 14224

Piedmont Healthcare/Research

Recruiting

Statesville, North Carolina, United States, 28625

Lillestol Research LLC

Recruiting

Fargo, North Dakota, United States, 58104

Geisinger Clinic

Recruiting

Danville, Pennsylvania, United States, 17822

Medical University Of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Hillcrest Clinical Research

Recruiting

Simpsonville, South Carolina, United States, 29681-1538

Spartanburg Medical Research

Recruiting

Spartanburg, South Carolina, United States, 29303

Amarillo Med Spec LLP

Recruiting

Amarillo, Texas, United States, 79124

Texas Diabetes & Endocrinology

Recruiting

Austin, Texas, United States, 78749

Pinnacle Clinical Research

Recruiting

Brownsville, Texas, United States, 78520

Osvaldo A. Brusco MD

Recruiting

Corpus Christi, Texas, United States, 78414

National Clin Res Inc.

Recruiting

Richmond, Virginia, United States, 23294

Rainier Clin Res Ctr Inc

Recruiting

Renton, Washington, United States, 98057

Seattle Clinical Research Center

Recruiting

Seattle, Washington, United States, 98104

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.