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NCT Number: NCT07720271

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pinnacle Research Group LLC, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18 and older (both inclusive) at time of signing the informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

zenagamtide

Drug

zenagamtide will be taken orally.

Placebo

Drug

Placebo matched to zenagamtide will be taken orally.

Primary outcomes

  1. Relative change in body weight

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

    Measured as percentage (%) change in body weight.

Secondary outcomes

  1. Change in waist circumference

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

    Measured as centimetre (cm)

  2. Change in systolic blood pressure (SBP)

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

    Measured as millimetre of mercury (mmHg).

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)

Acronym: AMAZE 9

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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