AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight
AMAZE 13
Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)
2 other identifiers
interventional
400
5 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Jan 2027
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
January 7, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2029
Study Completion
Last participant's last visit for all outcomes
January 11, 2029
July 21, 2026
July 1, 2026
2 years
June 18, 2026
July 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage of body weight.
From baseline (week 0) to week 80
Secondary Outcomes (1)
Change in waist circumference
From baseline (week 0) to week 80
Study Arms (2)
Zenagamtide
EXPERIMENTALParticipants will be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to Zenagamtide subcutaneously once weekly.
Interventions
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (41)
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002, India
SSG Hospital, Baroda
Vadodara, Gujarat, 390001, India
Karnataka Medical College and Research Institute
Hubbali, Karnataka, 580022, India
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010, India
Shree Mahalaxmi DIATONE Institute
Kohlapur, Maharashtra, 416001, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008, India
BSES MG hospital
Mumbai, Maharashtra, 400058, India
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, 441108, India
Shalini Tai Meghe Hospital and Research Center
Nagpur, Maharashtra, 441110, India
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005, India
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Chellaram Diabetes Institute
Pune, Maharashtra, 411021, India
Maulana Azad Medical College
Delhi, New Delhi, 110002, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004, India
Diabetes Research Center, Hyderabad
Hyderabad, Telangana, 500 082, India
Osmania General Hospital
Hyderabad, Telangana, 500012, India
All India Institute of Medical Science (AIIMS), Guwahati
Assam, 781101, India
SMS Hospital
Jaipur, 302004, India
GMERS Medical college and hospital
Vadodara, 390021, India
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853, Japan
Kindai University Hospital_Department of Endocrinology, Metabolism and Diabetes
Sakai-shi, Osaka, 590-0197, Japan
Medical Corporation Shinanokai Shinanozaka Clinic_Internal Medicine
Shinjuku-ku, Tokyo, 160-0017, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008, Japan
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Hospital Putrajaya
Putrajaya, 62250, Malaysia
Seoul National University Bundang Hospital_Endocrinology
Seoungnam-si, Gyeonggi-do, 13620, South Korea
Ajou University Hospital_Family Medicine
Suwon, Gyeonggi-do, 16499, South Korea
Pusan National University Yangsan Hospital_Family Medicine
Yangsan, Gyeongsangnam-do, 50612, South Korea
Kyungpook National University Hospital_Family Medicine
Daegu, 41944, South Korea
Konkuk University Medical Center_Endocrinology
Seoul, 05030, South Korea
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Institute of Clinical Research
Bangkok, 10700, Thailand
Thammasat Hospital_CRC
Pathum Thani, 12120, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 25, 2026
Study Start (Estimated)
January 7, 2027
Primary Completion (Estimated)
January 11, 2029
Study Completion (Estimated)
January 11, 2029
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com