AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Part of paid clinical trials in San Diego, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT07571005
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 excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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
Jul 12, 2028
Completion
Oct 4, 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 (17)

FacilityCityStateZIPSite coordinators
Artemis Insitute for Clin ResSan DiegoCalifornia92123-
PharmaDev Clinical Research Institute LLCMiamiFlorida33176-
Essence MD ResearchNaplesFlorida34102-
Renstar Medical ResearchOcalaFlorida34470-
Conquest ResearchAtlantaGeorgia30328-
Physicians Research AssociatesLawrencevilleGeorgia30046-
University Of ChicagoChicagoIllinois60637-
Weil Cornell MedicineNew YorkNew York10021-
CTI Clinical Research CenterCincinnatiOhio45212-
Clinical Research Associates of Central PA, LLCDuBoisPennsylvania15801-
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-

Find similar trials in San Diego, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Artemis Insitute for Clin Res· San Diego, CAPharmaDev Clinical Research Institute LLC· Miami, FLEssence MD Research· Naples, FLRenstar Medical Research· Ocala, FLConquest Research· Atlanta, GAPhysicians Research Associates· Lawrenceville, GA

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