Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT06771115Other idVTX3232-204Other idJ7V-MC-EOBA

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 175 participants (actual)
Sponsor: Zomagen Biosciences Ltd. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 7 Jan 2025
Primary completion: 10 Sept 2025
Completion: 10 Sept 2025
First posted: 13 Jan 2025
Last update posted: 29 Sept 2026
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026

Ph 2
Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity
NCT06771115
7 Jan 2025 to 10 Sept 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study evaluated the safety of VTX3232 administered alone or in combination with semaglutide in participants with obesity. Approximately 160 participants were randomized to receive VTX3232 30 mg, placebo, VTX3232 30 mg in combination with semaglutide, or placebo in combination with semaglutide. The study consisted of a 30-day screening period, a 12-week double-blind treatment period, and a 30-day follow-up period. The maximum treatment duration was 12 weeks.

Interventions

PlaceboDrug
VTX3232 30 mgDrug
Placebo in combination with semaglutideDrug
VTX3232 30 mg in combination with semaglutideDrug

Arms4

Placebo comparator
Placebo
Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose.
Experimental
VTX3232 30 mg
Participants received VTX3232 30 milligrams (mg) orally once daily for 12 weeks and were followed for 30 days after the last dose.
Active comparator
Placebo + Semaglutide
Participants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.
Experimental
VTX3232 30 mg + Semaglutide
Participants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
Time frame · From the first dose of study treatment to Week 16
Registry description
A TEAE was defined as any adverse event that occurred after initiation of study treatment or any pre-existing adverse event that worsened in severity following initiation of study treatment.

Secondary outcomes(1)

Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (Hs-CRP) Level
Time frame · From baseline to Week 12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From the first dose of study treatment to Week 16

Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)

Group	Value (Participants)
Placebo	21
VTX3232 30 mg	20
Placebo + Semaglutide	24
VTX3232 30 mg + Semaglutide	25

Secondary and other outcome results(1)

Secondary outcomeMedian· From baseline to Week 12

Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (Hs-CRP) Level

Group	Value (Percent change)
Placebo	2.98
VTX3232 30 mg	-63.77
Placebo + Semaglutide	-28.11
VTX3232 30 mg + Semaglutide	-75.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose.	0 / 43	0 / 43	13 / 43
VTX3232 30 mgParticipants received VTX3232 30 mg orally once daily for 12 weeks and were followed for 30 days after the last dose.	0 / 44	1 / 44	10 / 44
Placebo + SemaglutideParticipants received placebo orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.	0 / 43	0 / 43	20 / 43
VTX3232 30 mg + SemaglutideParticipants received VTX3232 30 mg orally once daily for 12 weeks and semaglutide administered subcutaneously once weekly for 12 weeks. Semaglutide doses were 0.25 mg during Weeks 0 - 3, 0.5 mg during Weeks 4 - 7 and 1.0 mg during Weeks 8 - 11. Participants were followed for 30 days after the last dose.	0 / 45	0 / 45	22 / 45

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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