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

Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07668414
Acronym
AMAZE 7
Enrollment
650
Registered
2026-06-25
Start date
2026-09-22
Completion date
2028-10-10
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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.

Interventions

DRUGSemaglutide

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

DRUGPlacebo (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.

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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Relative change in body weightFrom week 0 to week 84Measured as percentage (%) change in body weight.

Secondary

MeasureTime frameDescription
Change in waist circumferenceFrom week 0 to week 84Measured as centimetre (cm).

Countries

United States

Contacts

CONTACTNovo Nordisk
clinicaltrials@novonordisk.com(+1) 866-867-7178
STUDY_DIRECTORClinical Transparency (dept. 2834)

Novo Nordisk A/S

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026