Health Trials

AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight

ConditionsOverweightObesity
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 oral tablets once a day. Participants will either get zenagamtide (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female (sex at birth).

Age 18 and older (both inclusive) at time of signing the informed consent.

Disqualifiers

Glycated haemoglobin (HbA1c) more than or equal to (≥) 6.5% [48 millimoles per mole (mmol/mol)] as measured by the central laboratory at screening.

History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.

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

Design model

Parallel

Treatments tested in this trial

  • zenagamtide

    Drug

    zenagamtide will be taken orally.

  • Placebo

    Drug

    Placebo matched to zenagamtide will be taken orally.

Treatment groups

950 Participants
are divided into 2 treatment groups
Group A: zenagamtideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relative change in body weight

Measured as percentage (%) change in body weight.

Time frame
From baseline (week 0) to (week 76)

Secondary outcomes

1

Change in waist circumference

Measured as centimetre (cm)

Time frame
From baseline (week 0) to (week 76)
2

Change in systolic blood pressure (SBP)

Measured as millimetre of mercury (mmHg).

Time frame
From baseline (week 0) to (week 76)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: