Clinical trial
AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight
Opening soon · Phase 3 · 5 countries · Registry ID NCT07668401
Opening soonPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight
Full registry 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.
Treatments and study arms
Zenagamtide
Drug
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)
Drug
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 outcomes
Relative change in body weightFrom baseline (week 0) to week 80
Measured as percentage of body weight.
Study locations
44 locations were listed when this page was built. The first 40 are shown.
All India Institute of Medical Science (AIIMS), Guwahati🇮🇳 Assam, India
Madras Diabetes Research Foundation🇮🇳 Chennai, Tamil Nadu, India
Maulana Azad Medical College🇮🇳 Delhi, New Delhi, India
Karnataka Medical College and Research Institute🇮🇳 Hubbali, Karnataka, India
Diabetes Research Center, Hyderabad🇮🇳 Hyderabad, Telangana, India
Osmania General Hospital🇮🇳 Hyderabad, Telangana, India
TOTALL Diabetes Hormone Institute🇮🇳 Indore, Madhya Pradesh, India
SMS Hospital🇮🇳 Jaipur, India
Shree Mahalaxmi DIATONE Institute🇮🇳 Kohlapur, Maharashtra, India
Excel Endocrine Centre🇮🇳 Kolhāpur, Maharashtra, India
Government Medical College, Kozhikode🇮🇳 Kozhikode, Kerala, India
BSES MG hospital🇮🇳 Mumbai, Maharashtra, India
All India Institute of Medical Sciences (AIIMS), Nagpur🇮🇳 Nagpur, Maharashtra, India
Shalini Tai Meghe Hospital and Research Center🇮🇳 Nagpur, Maharashtra, India
Vijan Hospital & Research Centre🇮🇳 Nashik, Maharashtra, India
Chellaram Diabetes Institute🇮🇳 Pune, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic🇮🇳 Pune, Maharashtra, India
Nirmal Hospital Pvt. Ltd.🇮🇳 Surat, Gujarat, India
GMERS Medical college and hospital🇮🇳 Vadodara, India
SSG Hospital, Baroda🇮🇳 Vadodara, Gujarat, India
Christian Medical College Hospital, Vellore🇮🇳 Vellore, Tamil Nadu, India
Kindai University Hospital_Department of Endocrinology, Metabolism and Diabetes🇯🇵 Sakai-shi, Osaka, Japan
Medical Corporation Shinanokai Shinanozaka Clinic_Internal Medicine🇯🇵 Shinjuku-ku, Tokyo, Japan
OCROM Clinic_Internal medicine🇯🇵 Suita-shi, Osaka, Japan
Fukuwa Clinic_Internal Medicine🇯🇵 Tokyo, Japan
ToCROM Clinic_Internal Medicine🇯🇵 Tokyo, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine🇯🇵 Tokyo, Japan
Hospital Canselor Tuanku Muhriz UKM🇲🇾 Cheras, Kuala Lumpur, Malaysia
University Malaya Medical Centre🇲🇾 Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Melaka🇲🇾 Malacca, Malaysia
Hospital Miri🇲🇾 Miri, Sarawak, Malaysia
Hospital Putrajaya🇲🇾 Putrajaya, Malaysia
Kyungpook National University Hospital_Family Medicine🇰🇷 Daegu, South Korea
Konkuk University Medical Center_Endocrinology🇰🇷 Seoul, South Korea
Seoul National University Hospital_Family Medicine🇰🇷 Seoul, South Korea
Severance Hospital, Yonsei University Health System_Family Medicine🇰🇷 Seoul, South Korea
Seoul National University Bundang Hospital_Endocrinology🇰🇷 Seoungnam-si, Gyeonggi-do, South Korea
Ajou University Hospital_Family Medicine🇰🇷 Suwon, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital_Family Medicine🇰🇷 Yangsan, Gyeongsangnam-do, South Korea
Ramathibodi Hospital🇹🇭 Bangkok, Thailand