Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: VTX3232 Dose A; Drug: VTX3232 Dose A in combination with semaglutide; Drug: Placebo in combination with semaglutide

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • 840005
  • California
    • Lake Forest, California, United States, 92630
      • 840003
    • Long Beach, California, United States, 90815
      • 840011
  • Florida
    • Largo, Florida, United States, 33761
      • 840001
    • Ocoee, Florida, United States, 34761
      • 840012
    • Port Orange, Florida, United States, 32127
      • 840016
  • Kansas
    • Newton, Kansas, United States, 67114
      • 840014
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • 840015
    • Marrero, Louisiana, United States, 70072
      • 840017
  • Texas
    • Austin, Texas, United States, 78705
      • 840002
    • Dallas, Texas, United States, 75230
      • 840006
    • San Antonio, Texas, United States, 78229
      • 840013
    • San Antonio, Texas, United States, 78229
      • 840018
    • Waco, Texas, United States, 76710
      • 840010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Obesity induced by endocrinologic disorders, or diagnosed genetic or syndromic forms of obesity
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: VTX3232 Dose A	Drug: VTX3232 Dose A; VTX3232 Dose A
Experimental: VTX3232 Dose A in combination with semaglutide	Drug: VTX3232 Dose A in combination with semaglutide; VTX3232 Dose A in combination with semaglutide
Experimental: Placebo in combination with semaglutide	Drug: Placebo in combination with semaglutide; Placebo in combination with semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate and Severity of Adverse Event (AE), Serious Adverse Event (SAE), and AEs leading to study treatment discontinuation through study completion	Incidence of AEs and SAEs and AEs leading to study treatment discontinuation	Day 1 of treatment period through study completion, up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in hs-CRP level	Change from baseline in hs-CRP through 12 weeks of study treatment	Day 1 of treatment period to week 12 of treatment period

Collaborators and Investigators

• Sponsor: Zomagen Biosciences Ltd.
• Investigators: Study Director: Snehal Naik, PhD, Zomagen Biosciences Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): September 10, 2025
• Study Completion (Actual): September 10, 2025

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Zomagen; VTX3232; NLRP3 Inhibitor
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: VTX3232-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No