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 — DRUGUBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
- Placebo — DRUGPlacebo 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 - UBT251Participants will be randomized to receive multiple dose levels subcutaneously.
- Placebo Comparator: Part A - placeboParticipants 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 - placeboParticipants will receive placebo matching one of the UBT251 arms subcutaneously.
- Experimental: Part C - UBT251 dose 1Participants will be randomized to receive dose level 1 subcutaneously.
- Experimental: Part C - UBT251 dose 2Participants will be randomized to receive dose level 2 subcutaneously.
- Experimental: Part C - UBT251 dose 3Participants 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
- Novo Nordisk(+1) 866-867-7178
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Altasciences Clinical LA, Inc. | Cypress | California | 90630 | - |
| Altasciences Clinical Kansas, Inc. | Overland Park | Kansas | 66212 | - |
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