AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight

NCT07668401 — Phase 3, Not yet recruiting, 400 participants, Novo Nordisk A/S
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)

RegistryNCT07668401, acronym AMAZE 13
StatusNot yet recruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment400 (Estimated)
SponsorNovo Nordisk A/S (Industry)
ConditionsObesity, Overweight
InterventionsZenagamtide, Placebo ( matched to Zenagamtide) (Drug)
Datesstart 2027-01-07 (estimated), primary completion 2029-01-11 (estimated), completion 2029-01-11 (estimated), first posted 2026-06-25, last updated 2026-08-24
Locations44 sites in India, Japan, Malaysia, South Korea, Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials for Overweight All trials of Zenagamtide All trials of Placebo ( matched to Zenagamtide)

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
ZenagamtideExperimentalDrug: ZenagamtideParticipants will be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly.
PlaceboPlacebo comparatorDrug: Placebo ( matched to Zenagamtide)Participants will receive placebo matched to Zenagamtide subcutaneously once weekly.
  • 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.

+Outcome measures

Primary outcomes

  • Relative change in body weight [From baseline (week 0) to week 80]: Measured as percentage of body weight.

Secondary outcomes

  • Change in waist circumference [From baseline (week 0) to week 80]: Measured as centimetre (cm).

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (44)

FacilityCityCountryStatus
Nirmal Hospital Pvt. Ltd.Surat, GujaratIndia
SSG Hospital, BarodaVadodara, GujaratIndia
Karnataka Medical College and Research InstituteHubbali, KarnatakaIndia
Government Medical College, KozhikodeKozhikode, KeralaIndia
TOTALL Diabetes Hormone InstituteIndore, Madhya PradeshIndia
Shree Mahalaxmi DIATONE InstituteKohlapur, MaharashtraIndia
Excel Endocrine CentreKolhāpur, MaharashtraIndia
BSES MG hospitalMumbai, MaharashtraIndia
All India Institute of Medical Sciences (AIIMS), NagpurNagpur, MaharashtraIndia
Shalini Tai Meghe Hospital and Research CenterNagpur, MaharashtraIndia
Vijan Hospital & Research CentreNashik, MaharashtraIndia
Grant Medical Foundation Ruby Hall ClinicPune, MaharashtraIndia
Chellaram Diabetes InstitutePune, MaharashtraIndia
Maulana Azad Medical CollegeDelhi, New DelhiIndia
Madras Diabetes Research FoundationChennai, Tamil NaduIndia
Christian Medical College Hospital, VelloreVellore, Tamil NaduIndia
Diabetes Research Center, HyderabadHyderabad, TelanganaIndia
Osmania General HospitalHyderabad, TelanganaIndia
All India Institute of Medical Science (AIIMS), GuwahatiAssamIndia
SMS HospitalJaipurIndia
GMERS Medical college and hospitalVadodaraIndia
OCROM Clinic_Internal medicineSuita-shi, OsakaJapan
Kindai University Hospital_Department of Endocrinology, Metabolism and DiabetesSakai-shi, OsakaJapan
Medical Corporation Shinanokai Shinanozaka Clinic_Internal MedicineShinjuku-ku, TokyoJapan
Tokyo-Eki Center-building Clinic_Internal MedicineTokyoJapan
Fukuwa Clinic_Internal MedicineTokyoJapan
ToCROM Clinic_Internal MedicineTokyoJapan
Hospital Canselor Tuanku Muhriz UKMCheras, Kuala LumpurMalaysia
University Malaya Medical CentreLembah Pantai, Kuala LumpurMalaysia
Hospital MiriMiri, SarawakMalaysia
Hospital MelakaMalaccaMalaysia
Hospital PutrajayaPutrajayaMalaysia
Seoul National University Bundang Hospital_EndocrinologySeoungnam-si, Gyeonggi-doSouth Korea
Ajou University Hospital_Family MedicineSuwon, Gyeonggi-doSouth Korea
Pusan National University Yangsan Hospital_Family MedicineYangsan, Gyeongsangnam-doSouth Korea
Kyungpook National University Hospital_Family MedicineDaeguSouth Korea
Seoul National University Hospital_Family MedicineSeoulSouth Korea
Severance Hospital, Yonsei University Health System_Family MedicineSeoulSouth Korea
Konkuk University Medical Center_EndocrinologySeoulSouth Korea
Ramathibodi HospitalBangkokThailand
Siriraj Institute of Clinical ResearchBangkokThailand
Maharaj Nakorn Chiang MaiChiang MaiThailand
Thammasat Hospital_CRCPathum ThaniThailand
Songklanagarind HospitalSongkhlaThailand

+Investigators

  • Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S