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

NCT06771115 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: VTX3232-204
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Obesity

Keywords

NLRP3 Inhibitor; VTX3232; Zomagen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in hs-CRP level

  Day 1 of treatment period to week 12 of treatment period

Study Arms (4)

VTX3232 Dose A

EXPERIMENTAL

VTX3232 Dose A

Drug: VTX3232 Dose A

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

VTX3232 Dose A in combination with semaglutide

EXPERIMENTAL

VTX3232 Dose A in combination with semaglutide

Drug: VTX3232 Dose A in combination with semaglutide

Placebo in combination with semaglutide

EXPERIMENTAL

Placebo in combination with semaglutide

Drug: Placebo in combination with semaglutide

Interventions

VTX3232 Dose A DRUG

VTX3232 Dose A

VTX3232 Dose A

Placebo DRUG

Placebo

Placebo

VTX3232 Dose A in combination with semaglutide DRUG

VTX3232 Dose A in combination with semaglutide

VTX3232 Dose A in combination with semaglutide

Placebo in combination with semaglutide DRUG

Placebo in combination with semaglutide

Placebo in combination with semaglutide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Any immunosuppressive biologic or targeted therapy within 90 days prior to Day 1.
• Use of anti-inflammatory medications within 30 days prior to Day 1
• Colchicine within 30 days prior to Day 1.
• Glucose-lowering agent(s) administered for conditions other than diabetes within 90 days before screening.

Sponsors & Collaborators

• Zomagen Biosciences Ltd.: lead

Study Sites (14)

840005

Birmingham, Alabama, 35235, United States

Location

840003

Lake Forest, California, 92630, United States

Location

840011

Long Beach, California, 90815, United States

Location

840001

Largo, Florida, 33761, United States

Location

840012

Ocoee, Florida, 34761, United States

Location

840016

Port Orange, Florida, 32127, United States

Location

840014

Newton, Kansas, 67114, United States

Location

840015

Marrero, Louisiana, 70072, United States

Location

840017

Marrero, Louisiana, 70072, United States

Location

840002

Austin, Texas, 78705, United States

Location

840006

Dallas, Texas, 75230, United States

Location

840013

San Antonio, Texas, 78229, United States

Location

840018

San Antonio, Texas, 78229, United States

Location

840010

Waco, Texas, 76710, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Snehal Naik, PhD

  Zomagen Biosciences Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will employ a double-blind design for study treatment tablets (i.e., VTX3232 or Placebo); assignment to treatment group with semaglutide injections plus study treatment tablets or to treatment group with study treatment tablets alone will not be blinded. Participants, Investigators, study center staff, persons performing the assessments, and the Sponsor are to remain blinded to the identity of the study treatment tablets from the time of randomization until the database lock for the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 7, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (14)