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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Zenagamtide
  • Placebo ( matched to Zenagamtide)

Treatment groups

400 Participants
are divided into 2 treatment groups

Locations

11
India
Nirmal Hospital Pvt. Ltd.395002, SuratGujarat, India
SSG Hospital, Baroda390001, VadodaraGujarat, India
Shree Mahalaxmi DIATONE Institute416001, KohlapurMaharashtra, India
Excel Endocrine Centre416008, KolhāpurMaharashtra, India

Sponsors and collaborators

Novo Nordisk A/S

Lead sponsor