AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Part of paid clinical trials in Miramar, Florida.

Sponsor
Novo Nordisk A/S
Study ID
NCT07339423
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NNC0487-0111 — DRUG
    NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
  • Placebo (matched to NNC0487-0111) — DRUG
    Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Study Details

The purpose of this clinical study is to find out if NNC0487-0111 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 NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Key Dates

Start date
Feb 24, 2026
Status verified
Jun 2026
Primary completion
Jun 26, 2029
Completion
Aug 21, 2029

Study Design

Enrollment
1,150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0487-0111
    Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to week 84 ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
South Broward Research LLCMiramarFlorida33027-
Clinical Neuroscience SolutionOrlandoFlorida32801-
Hope Clin Res & WellnessConyersGeorgia30094-
Endeavor HealthSkokieIllinois60077-
Midwest Inst For Clin ResIndianapolisIndiana46260-
StudyMetrix Research LLCCity of Saint PetersMissouri63303-
New York Gastroenterology AssociatesNew YorkNew York10075-
UNC Eastowne Medical OfficeChapel HillNorth Carolina27514-
PharmQuest Life Sciences LLCGreensboroNorth Carolina27408-
Accellacare and KDCILM, LLCWilmingtonNorth Carolina28401-
UPA Ctr Weight and Eating DisPhiladelphiaPennsylvania19104-
Clinical Res CollaborativeCumberlandRhode Island02864-
Medical Uni of SC CharlestonCharlestonSouth Carolina29425-
Coastal Carolina Research CtrNorth CharlestonSouth Carolina29405-
Hillcrest Clinical ResearchSimpsonvilleSouth Carolina29681-1538-
Amarillo Medical SpecialistsAmarilloTexas79124-
Velocity Clinical Res-DallasDallasTexas75230-6855-
Care United Research, LLCForneyTexas75126-
Washington Cntr Weight MgmtArlingtonVirginia22206-
Health Res of Hampton RoadsNewport NewsVirginia23606-
Selma Medical AssociatesWinchesterVirginia22601-3834-
Rainier Clin Res Ctr IncRentonWashington98057-

Find similar trials in Miramar, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
South Broward Research LLC· Miramar, FLClinical Neuroscience Solution· Orlando, FLHope Clin Res & Wellness· Conyers, GAEndeavor Health· Skokie, ILMidwest Inst For Clin Res· Indianapolis, INStudyMetrix Research LLC· City of Saint Peters, MO

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