A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity

Part of paid clinical trials in Cypress, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT07395687
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • UBT251 — DRUG
    UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
  • Placebo — DRUG
    Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Study Details

The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (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 2, 2026
Status verified
Apr 2026
Primary completion
Jan 14, 2027
Completion
Feb 18, 2027

Study Design

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

Arms

  • Experimental: Part A - UBT251
    Participants will be randomized to receive multiple dose levels subcutaneously.
  • Placebo Comparator: Part A - placebo
    Participants will receive placebo matched to UBT251 subcutaneously.
  • Experimental: Part B - Arm A (UBT251)
    Participants will be randomized to receive multiple dose levels subcutaneously.
  • Experimental: Part B - Arm B (UBT251)
    Participants will be randomized to receive multiple dose levels subcutaneously.
  • Experimental: Part B - Arm C (UBT251)
    Participants will be randomized to receive multiple dose levels subcutaneously.
  • Experimental: Part B - Arm D (UBT251)
    Participants will be randomized to receive 2 dose levels subcutaneously.
  • Experimental: Part B - Arm E (UBT251)
    Participants will be randomized to receive a single dose level subcutaneously.
  • Placebo Comparator: Part B - placebo
    Participants will receive placebo matching one of the UBT251 arms subcutaneously.
  • Experimental: Part C - UBT251 dose 1
    Participants will be randomized to receive dose level 1 subcutaneously.
  • Experimental: Part C - UBT251 dose 2
    Participants will be randomized to receive dose level 2 subcutaneously.
  • Experimental: Part C - UBT251 dose 3
    Participants will be randomized to receive dose level 3 subcutaneously.

Primary Outcome Measure

Part A - Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to end of study (week 33) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Altasciences Clinical LA, Inc.CypressCalifornia90630-
Altasciences Clinical Kansas, Inc.Overland ParkKansas66212-

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