AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Part of paid clinical trials in Hollywood, Florida.

Sponsor
Novo Nordisk A/S
Study ID
NCT07400107
Phase
PHASE3
Status
Not Yet Recruiting

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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.
  • Semaglutide — DRUG
    Semaglutide 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 pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
  • Placebo (matched to semaglutide) — DRUG
    Placebo matched to semaglutide will be administered subcutaneously using 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 and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

Key Dates

Start date
May 20, 2026
Status verified
Mar 2026
Primary completion
Dec 12, 2028
Completion
Jan 26, 2029

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0487-0111
    Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Active Comparator: Semaglutide
    Participants will receive semaglutide and 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 (10)

FacilityCityStateZIPSite coordinators
Encore Medical Research LLCHollywoodFlorida33024-
Optimal Research SitesOrange CityFlorida32763-
Encore Medical Research of WestonWestonFlorida33331-
Endocrine Research Solutions, IncRoswellGeorgia30076-
Elite Clinical TrialsBlackfootIdaho83221-
Endo And Metab ConsRockvilleMaryland20852-
Arcturus Healthcare, PLC.TroyMichigan48098-6368-
Velocity Clin Res, DallasDallasTexas75230-
Consano Clinical Research, LLCShavano ParkTexas78231-
Selma Medical AssociatesWinchesterVirginia22601-3834-

Find similar trials in Hollywood, FL

By condition
Type 2 diabetesObesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Encore Medical Research LLC· Hollywood, FLOptimal Research Sites· Orange City, FLEncore Medical Research of Weston· Weston, FLEndocrine Research Solutions, Inc· Roswell, GAElite Clinical Trials· Blackfoot, IDEndo And Metab Cons· Rockville, MD

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