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

NCT07720271
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
950
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Lead sponsor
Novo Nordisk A/S
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Start date
2026-08-31
clinicaltrials.gov
Number of sites
41
clinicaltrials.gov

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 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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Acronym
AMAZE 9
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Short title
AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight
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Official title
Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-08-22
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First posted
2026-07-22
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Registry last updated
2026-09-28
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Primary completion date
2028-06-27
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Start date
2026-08-31
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Participants
950
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Participant count basis
Estimated
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Planned participants
950
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Protocol amendments
0
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Number of sites
41
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07720271
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ClinicalTrials.gov ID
NCT07720271
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Relative change in body weight

    Timeframe: From baseline (week 0) to (week 76)

    Measured as percentage (%) change in body weight.

  1. Change in waist circumference

    Timeframe: From baseline (week 0) to (week 76)

    Measured as centimetre (cm)

  2. Change in systolic blood pressure (SBP)

    Timeframe: From baseline (week 0) to (week 76)

    Measured as millimetre of mercury (mmHg).

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group LLCAnniston, United StatesRecruiting
  • Univ of Alabama BirminghamBirmingham, United StatesRecruiting
  • Chambliss Clinical Trials LLCMontgomery, United StatesRecruiting
  • Providence Medical FoundationFullerton, United StatesRecruiting
  • Torrance Clinical Research Institute, Inc.Lomita, United StatesRecruiting
  • Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
  • Univ of Colorado at DenverAurora, United StatesRecruiting
  • Brain Matters ResearchDelray Beach, United StatesRecruiting
  • Northeast Research InstituteFleming Island, United StatesRecruiting
  • Miguel Rebollar PAHialeah, United StatesRecruiting
  • Jacksonville Ctr Clin ResJacksonville, United StatesRecruiting
  • South Broward Research LLCMiramar, United StatesRecruiting
  • Clinical Neuroscience SolutionOrlando, United StatesRecruiting
  • Florida Institute for Clinical Research, LLCOrlando, United StatesRecruiting
  • Oviedo Medical Research, LLCOviedo, United StatesRecruiting
  • Hope Clin Res & WellnessConyers, United StatesRecruiting
  • East West Medical Research Institute_HonoluluHonolulu, United StatesRecruiting
  • Great Lakes Clinical TrialsChicago, United StatesRecruiting
  • Clinical Investigation Spec GurneeGurnee, United StatesRecruiting
  • Endeavor HealthSkokie, United StatesRecruiting
  • Evanston Premier Hlthcr ResSkokie, United StatesRecruiting
  • Midwest Inst For Clin ResIndianapolis, United StatesNot yet recruiting
  • Northern Pines Hlth Ctr, PCBuckley, United StatesRecruiting
  • StudyMetrix Research LLCCity of Saint Peters, United StatesRecruiting
  • Palm Research Center Inc.Las Vegas, United StatesRecruiting

And 16 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1313-7267
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)