A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTX3232 Alone or in Combination With Semaglutide in Participants With Obesity

Status: Completed
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Participants are male or female ≥ 18 years up to ≤ 80 years of age.

• Ability to comply with study requirements.

• BMI ≥ 30.0 to ≤ 42.0 kg/m2 at screening.

• Stable body weight (± 5%) for at least 3 months prior to screening.

• hs-CRP ≥ 2 mg/L at screening.

• Hypertension or hyperlipidemia which are known to be associated with increased risk of cardiovascular events, if present, must be controlled with stable dose/therapy.

• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Locations
United States
Alabama
840005
Birmingham
California
840003
Lake Forest
840011
Long Beach
Florida
840001
Largo
840012
Ocoee
840016
Port Orange
Kansas
840014
Newton
Louisiana
840015
Marrero
840017
Marrero
Texas
840002
Austin
840006
Dallas
840013
San Antonio
840018
San Antonio
840010
Waco
Time Frame
Start Date: 2025-01-07
Completion Date: 2025-09-10
Participants
Target number of participants: 176
Treatments
Experimental: VTX3232 Dose A
VTX3232 Dose A
Placebo_comparator: Placebo
Placebo
Experimental: VTX3232 Dose A in combination with semaglutide
VTX3232 Dose A in combination with semaglutide
Experimental: Placebo in combination with semaglutide
Placebo in combination with semaglutide
Related Therapeutic Areas
Sponsors
Leads: Zomagen Biosciences Ltd.

This content was sourced from clinicaltrials.gov