AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight
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, Placebo.
- 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 Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
Overview
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.
Interventions
- Drug zenagamtide
zenagamtide will be taken orally. - Drug Placebo
Placebo matched to zenagamtide will be taken orally.
Primary outcome measures
- Relative change in body weight [Time frame: From baseline (week 0) to (week 76)]
Secondary outcome measures (2)
- Change in waist circumference [Time frame: From baseline (week 0) to (week 76)]
- Change in systolic blood pressure (SBP) [Time frame: From baseline (week 0) to (week 76)]
Eligibility criteria
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.
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 · 42 centers
- Pinnacle Research Group LLC — Anniston
- Univ of Alabama Birmingham — Birmingham
- Chambliss Clinical Trials LLC — Montgomery
- Providence Medical Foundation — Fullerton
- Torrance Clinical Research Institute, Inc. — Lomita
- Diablo Clinical Research, Inc. — Walnut Creek
- Univ of Colorado at Denver — Aurora
- ERG Holding Company, LLC / Evolution Research Group, LLC — Delray Beach
- … and 34 more centers
Identifiers
NCT: NCT07720271 · NN9487-8023 · U1111-1313-7267