Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Zomagen Biosciences Ltd.
- Study ID
- NCT06771115
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- VTX3232 Dose A — DRUGVTX3232 Dose A
- Placebo — DRUGPlacebo
- VTX3232 Dose A in combination with semaglutide — DRUGVTX3232 Dose A in combination with semaglutide
- Placebo in combination with semaglutide — DRUGPlacebo in combination with semaglutide
Study Details
This is a study to understand if taking VTX3232 alone or in combination with semaglutide is safe in participants diagnosed with Obesity. Approximately 160 patients will take VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide. This study consists of a 30-day Screening Period (to see if a participant qualifies for a study), a 12-week double-blind treatment period (a participant receives VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide), and a 30-day Follow-Up Period. The maximum duration of treatment will be approximately 12 weeks.
Key Dates
- Start date
- Jan 7, 2025
- Status verified
- Nov 2025
- Primary completion
- Sep 10, 2025
- Completion
- Sep 10, 2025
Study Design
- Enrollment
- 176 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: VTX3232 Dose AVTX3232 Dose A
- Placebo Comparator: PlaceboPlacebo
- Experimental: VTX3232 Dose A in combination with semaglutideVTX3232 Dose A in combination with semaglutide
- Experimental: Placebo in combination with semaglutidePlacebo in combination with semaglutide
Primary Outcome Measure
Incidence Rate and Severity of Adverse Event (AE), Serious Adverse Event (SAE), and AEs leading to study treatment discontinuation through study completion [ Time Frame: Day 1 of treatment period through study completion, up to 16 weeks ]
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| 840005 | Birmingham | Alabama | 35235 | - |
| 840003 | Lake Forest | California | 92630 | - |
| 840011 | Long Beach | California | 90815 | - |
| 840001 | Largo | Florida | 33761 | - |
| 840012 | Ocoee | Florida | 34761 | - |
| 840016 | Port Orange | Florida | 32127 | - |
| 840014 | Newton | Kansas | 67114 | - |
| 840015 | Marrero | Louisiana | 70072 | - |
| 840017 | Marrero | Louisiana | 70072 | - |
| 840002 | Austin | Texas | 78705 | - |
| 840006 | Dallas | Texas | 75230 | - |
| 840013 | San Antonio | Texas | 78229 | - |
| 840018 | San Antonio | Texas | 78229 | - |
| 840010 | Waco | Texas | 76710 | - |
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