AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Novo Nordisk A/S
Study ID
NCT07571109
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

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. 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) and which treatment participants get is decided by chance.

Key Dates

Start date
May 5, 2026
Status verified
Jun 2026
Primary completion
Jun 26, 2028
Completion
Aug 21, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0487-0111
    Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 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 80) ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Dignity Health, Mercy GilbertGilbertArizona85297-
DM ClinicalBradentonFlorida34209-
Essence MD ResearchNaplesFlorida34102-
Palm Beach Research CenterWest Palm BeachFlorida33409-
NeuroTrials Research, Inc.AtlantaGeorgia30328-
Physicians Research AssociatesLawrencevilleGeorgia30046-
Chicago Research Center, IncChicagoIllinois60634-
Weil Cornell MedicineNew YorkNew York10021-
Lillestol Research LLCFargoNorth Dakota58104-
CTI Clinical Research CenterCincinnatiOhio45212-
Clinical Research Associates of Central PA, LLCDuBoisPennsylvania15801-
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201-
Epic Medical ResearchDeSotoTexas75115-
Advanced Neurology Epilepsy and Sleep Center ANESCEl PasoTexas79912-
Biorhythms Center for Integrative Sleep MedicineEl PasoTexas79912-
Houston Pulmonary Medicine Associates, PAHoustonTexas77089-
Sleep Therapy Research CenterSan AntonioTexas78229-
Tricoastal Sleep CenterSugar LandTexas77478-
Rainier Clin Res Ctr IncRentonWashington98057-
Seattle Clinical Research CenterSeattleWashington98104-

Find similar trials in Gilbert, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Dignity Health, Mercy Gilbert· Gilbert, AZDM Clinical· Bradenton, FLEssence MD Research· Naples, FLPalm Beach Research Center· West Palm Beach, FLNeuroTrials Research, Inc.· Atlanta, GAPhysicians Research Associates· Lawrenceville, GA

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