AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia 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 ( matched to Zenagamtide).
- Who it may be relevant to
- Registry conditions: Obesity, Overweight. 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
- India, Japan, Malaysia, South Korea, Thailand
- 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 in Asian Participants With Overweight or Obesity (AMAZE 13)
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 injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Interventions
- Drug Zenagamtide
Zenagamtide will be administered subcutaneously using PDS290 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 PDS290 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 baseline (week 0) to week 80]
Secondary outcome measures (1)
- Change in waist circumference [Time frame: From baseline (week 0) to week 80]
Eligibility criteria
Inclusion criteria
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent
Exclusion criteria
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- 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
India · 21 centers
- Nirmal Hospital Pvt. Ltd. — Surat
- SSG Hospital, Baroda — Vadodara
- Karnataka Medical College and Research Institute — Hubbali
- Government Medical College, Kozhikode — Kozhikode
- TOTALL Diabetes Hormone Institute — Indore
- Shree Mahalaxmi DIATONE Institute — Kohlapur
- Excel Endocrine Centre — Kolhāpur
- BSES MG hospital — Mumbai
- … and 13 more centers
Japan · 6 centers
- OCROM Clinic_Internal medicine — Suita-shi
- Kindai University Hospital_Department of Endocrinology, Metabolism and Diabetes — Sakai-shi, Osaka
- Medical Corporation Shinanokai Shinanozaka Clinic_Internal Medicine — Shinjuku-ku, Tokyo
- Tokyo-Eki Center-building Clinic_Internal Medicine — Tokyo
- Fukuwa Clinic_Internal Medicine — Tokyo
- ToCROM Clinic_Internal Medicine — Tokyo
Malaysia · 5 centers
- Hospital Canselor Tuanku Muhriz UKM — Cheras
- University Malaya Medical Centre — Lembah Pantai
- Hospital Miri — Miri
- Hospital Melaka — Malacca
- Hospital Putrajaya — Putrajaya
South Korea · 5 centers
- Seoul National University Bundang Hospital_Endocrinology — Seoungnam-si
- Ajou University Hospital_Family Medicine — Suwon
- Pusan National University Yangsan Hospital_Family Medicine — Yangsan
- Kyungpook National University Hospital_Family Medicine — Daegu
- Konkuk University Medical Center_Endocrinology — Seoul
Thailand · 4 centers
- Ramathibodi Hospital — Bangkok
- Siriraj Institute of Clinical Research — Bangkok
- Thammasat Hospital_CRC — Pathum Thani
- Songklanagarind Hospital — Songkhla
Identifiers
NCT: NCT07668401 · NN9490-8731 · U1111-1335-9475