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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT07533175
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 and type 2 diabetes. 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 (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Key Dates

Start date
Apr 13, 2026
Status verified
Jun 2026
Primary completion
Aug 7, 2028
Completion
Aug 7, 2028

Study Design

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

Arms

  • Experimental: NNC0487-0111 dose level 1
    Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Experimental: NNC0487-0111 dose level 2
    Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Experimental: NNC0487-0111 dose level 3
    Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Experimental: NNC0487-0111 dose level 4
    Participants will be randomized to receive NNC0487-0111 dose level 4 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 (15)

FacilityCityStateZIPSite coordinators
Univ of Alabama BirminghamBirminghamAlabama35294-
Headlands Research California, LLCEscondidoCalifornia92025-
Torrance Clinical Research Institute, Inc.LomitaCalifornia90717-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Northeast Research InstituteFleming IslandFlorida32003-
Jacksonville Ctr Clin ResJacksonvilleFlorida32216-
Florida Institute for Clinical Research, LLCOrlandoFlorida32825-
Oviedo Medical Research, LLCOviedoFlorida32765-
International Diabetes CenterMinneapolisMinnesota55416-
Southgate Medical Group, LLPWest SenecaNew York14224-
Spartanburg Medical ResearchSpartanburgSouth Carolina29303-
M3 Wake Research ChattanoogaChattanoogaTennessee37421-
UT Southwestern Medical Center - LingvayDallasTexas75390-
PlanIt Research, PLLCHoustonTexas77079-
National Clin Res Inc.RichmondVirginia23294-

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Univ of Alabama Birmingham· Birmingham, ALHeadlands Research California, LLC· Escondido, CATorrance Clinical Research Institute, Inc.· Lomita, CADiablo Clinical Research, Inc.· Walnut Creek, CANortheast Research Institute· Fleming Island, FLJacksonville Ctr Clin Res· Jacksonville, FL

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