COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-07

Study Completion:2025-09-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06771115

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Snehal Naik, PhD

STUDY_DIRECTOR

Zomagen Biosciences Ltd.

Study Locations (Sites)

840005

Birmingham, Alabama, 35235

United States

840003

Lake Forest, California, 92630

United States

840011

Long Beach, California, 90815

United States

840001

Largo, Florida, 33761

United States

840012

Ocoee, Florida, 34761

United States

840016

Port Orange, Florida, 32127

United States

840014

Newton, Kansas, 67114

United States

840015

Marrero, Louisiana, 70072

United States

840017

Marrero, Louisiana, 70072

United States

840002

Austin, Texas, 78705

United States

840006

Dallas, Texas, 75230

United States

840013

San Antonio, Texas, 78229

United States

840018

San Antonio, Texas, 78229

United States

840010

Waco, Texas, 76710

United States

Collaborators and Investigators

Sponsor: Zomagen Biosciences Ltd.

Snehal Naik, PhD, STUDY_DIRECTOR, Zomagen Biosciences Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-07

Study Completion Date2025-09-10

Study Record Updates

Study Start Date2025-01-07

Study Completion Date2025-09-10

Terms related to this study

Keywords Provided by Researchers

NLRP3 Inhibitor
VTX3232
Zomagen

Additional Relevant MeSH Terms

Obesity