Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity
NCT ID: NCT06771115
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2025-01-07
2025-09-10
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VTX3232 Dose A
VTX3232 Dose A
VTX3232 Dose A
VTX3232 Dose A
Placebo
Placebo
Placebo
Placebo
VTX3232 Dose A in combination with semaglutide
VTX3232 Dose A in combination with semaglutide
VTX3232 Dose A in combination with semaglutide
VTX3232 Dose A in combination with semaglutide
Placebo in combination with semaglutide
Placebo in combination with semaglutide
Placebo in combination with semaglutide
Placebo in combination with semaglutide
Interventions
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VTX3232 Dose A
VTX3232 Dose A
Placebo
Placebo
VTX3232 Dose A in combination with semaglutide
VTX3232 Dose A in combination with semaglutide
Placebo in combination with semaglutide
Placebo in combination with semaglutide
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Have any prior diagnosis of diabetes mellitus
* Current participation (or within the last 3 months) in an organized weight reduction program.
* History or presence of clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass \[bariatric\] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity.
* Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
* Use of any medication (e.g., GLP-1 agonists), nutritional supplement, or over the counter product for weight loss within the previous 6 months or during study participation, unless administered as a part of assigned study treatment in this study.
* Receipt of the following medications:
1. Any immunosuppressive biologic or targeted therapy within 90 days prior to Day 1.
2. Use of anti-inflammatory medications within 30 days prior to Day 1
3. Colchicine within 30 days prior to Day 1.
4. Glucose-lowering agent(s) administered for conditions other than diabetes within 90 days before screening.
18 Years
80 Years
ALL
No
Sponsors
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Zomagen Biosciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Snehal Naik, PhD
Role: STUDY_DIRECTOR
Zomagen Biosciences Ltd.
Locations
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840005
Birmingham, Alabama, United States
840003
Lake Forest, California, United States
840011
Long Beach, California, United States
840001
Largo, Florida, United States
840012
Ocoee, Florida, United States
840016
Port Orange, Florida, United States
840014
Newton, Kansas, United States
840015
Marrero, Louisiana, United States
840017
Marrero, Louisiana, United States
840002
Austin, Texas, United States
840006
Dallas, Texas, United States
840013
San Antonio, Texas, United States
840018
San Antonio, Texas, United States
840010
Waco, Texas, United States
Countries
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Other Identifiers
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VTX3232-204
Identifier Type: -
Identifier Source: org_study_id