Not yet recruiting NCT07668414
A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zenagamtide, Semaglutide, Placebo (matched to semaglutide), Placebo (matched to zenagamtide).
- Who it may be relevant to
- Registry conditions: Overweight, Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)
Overview
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
- Drug Zenagamtide
Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. - Drug Semaglutide
Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. - Drug 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. - Drug 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 measures
- Relative change in body weight [Time frame: From week 0 to week 84]
Secondary outcome measures (1)
- Change in waist circumference [Time frame: From week 0 to week 84]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 46 centers
- First Valley Medical Group — Lancaster
- Desert Oasis Healthcare — Palm Springs
- Western University of Health Sciences — Pomona
- Artemis Insitute for Clin Res — San Diego
- Med Home Development Grp — Washington D.C.
- Encore Medical Research LLC — Hollywood
- NextPhase Research — Hollywood
- Jacksonville Ctr Clin Res — Jacksonville
- … and 38 more centers
Identifiers
NCT: NCT07668414 · NN9490-8027 · U1111-1313-7968