Completed

VTX3232 and Semaglutide for Obesity Safety Evaluation

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What is being tested

VTX3232 Dose A

+ Placebo

+ VTX3232 Dose A in combination with semaglutide

Drug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorZomagen Biosciences Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 7, 2025

Actual date on which the first participant was enrolled.

The study is focused on understanding the safety of the drug VTX3232, whether used alone or together with another medication called semaglutide, in people who are diagnosed with obesity. This research involves approximately 160 participants who will be randomly assigned to receive either VTX3232, a placebo (a substance with no active drug), VTX3232 combined with semaglutide, or a placebo combined with semaglutide. The importance of this study lies in potentially finding new effective treatment options for obesity, a condition that can lead to various health issues. Participants in the study will first go through a 30-day screening period to determine if they qualify for the study. Those who qualify will then undergo a 12-week treatment phase where they receive one of the four potential treatments in a double-blind fashion, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo. After the treatment phase, participants will have a 30-day follow-up period. The study aims to measure the safety and tolerability of these treatments, alongside understanding how the body processes the drug and its effects, helping to gather valuable information about potential new treatments for obesity.

Official TitleA 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
NCT06771115
Principal SponsorZomagen Biosciences Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

176 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
VTX3232 Dose A

Group II

Placebo
Placebo

Group III

Experimental
VTX3232 Dose A in combination with semaglutide

Group IV

Experimental
Placebo in combination with semaglutide

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Suspended

840005

Birmingham, United StatesOpen 840005 in Google Maps
Suspended

840003

Lake Forest, United States
Suspended

840011

Long Beach, United States
Suspended

840001

Largo, United States
Completed14 Study Centers