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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Lake Forest

840003, Lake Forest, California, United States, 92630

Long Beach

840011, Long Beach, California, United States, 90815

Ocoee

840012, Ocoee, Florida, United States, 34761

Marrero

840015, Marrero, Louisiana, United States, 70072

Austin

840002, Austin, Texas, United States, 78705

Dallas

840006, Dallas, Texas, United States, 75230

San Antonio

840013, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zomagen Biosciences Ltd.,

Snehal Naik, PhD, STUDY_DIRECTOR, Zomagen Biosciences Ltd.

Study Record Dates

2025-06