ObesityPhase 2NCT06771115
Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity
A Phase 2 study testing VTX3232 30 mg and VTX3232 30 mg in combination with semaglutide in people with Obesity, run by Zomagen Biosciences Ltd. at 14 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- VTX3232 30 mg and VTX3232 30 mg in combination with semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 14 sitesUnited States
- Study dates
- 7 Jan 2025to 10 Sep 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
840002
Austin, Texas, 78705
840005
Birmingham, Alabama, 35235
840006
Dallas, Texas, 75230
840003
Lake Forest, California, 92630
840001
Largo, Florida, 33761
840011
Long Beach, California, 90815
840015
Marrero, Louisiana, 70072
840017
Marrero, Louisiana, 70072
840014
Newton, Kansas, 67114
840012
Ocoee, Florida, 34761
840016
Port Orange, Florida, 32127
840013
San Antonio, Texas, 78229
840018
San Antonio, Texas, 78229
840010
Waco, Texas, 76710
About this study
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
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.
- Conditions
- Obesity
- Being tested
- Placebo, VTX3232 30 mg, Placebo in combination with semaglutide, VTX3232 30 mg in combination with semaglutide
- Keywords
- NLRP3 Inhibitor, VTX3232, Zomagen
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
VTX3232 30 mgDrug
VTX3232 30 mg
Placebo in combination with semaglutideDrug
Placebo in combination with semaglutide
VTX3232 30 mg in combination with semaglutideDrug
VTX3232 30 mg in combination with semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose. Receives: Drug: Placebo |
| VTX3232 30 mg | Experimental | Participants received VTX3232 30 milligrams (mg) orally once daily for 12 weeks and were followed for 30 days after the last dose. Receives: Drug: VTX3232 30 mg |
| Placebo + Semaglutide | Active comparator | 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. Receives: Drug: Placebo in combination with semaglutide |
| VTX3232 30 mg + Semaglutide | Experimental | 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. Receives: Drug: VTX3232 30 mg in combination with semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
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.
Measured: From the first dose of study treatment to Week 16
Secondary outcomes (1)
Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (Hs-CRP) Level
Measured: From baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start7 Jan 2025
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zomagen Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Snehal Naik, PhD, Study director, Zomagen Biosciences Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771115
- Sponsor's protocol ID
- VTX3232-204
- Other IDs
- J7V-MC-EOBA
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2025
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06771115
- Acronym / sponsor ID
- VTX3232-204
- Conditions
- Obesity
- Keywords
- NLRP3 Inhibitor, VTX3232, Zomagen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Zomagen Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose. |
| VTX3232 30 mg | Experimental | Drug: VTX3232 30 mgParticipants received VTX3232 30 milligrams (mg) orally once daily for 12 weeks and were followed for 30 days after the last dose. |
| Placebo + Semaglutide | Active comparator | Drug: Placebo in combination with 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. |
| VTX3232 30 mg + Semaglutide | Experimental | Drug: VTX3232 30 mg in combination with 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| VTX3232 30 mgVTX3232 30 mg | Drug | VTX3232 30 mg |
| Placebo in combination with semaglutidePlacebo in combination with semaglutide | Drug | Placebo + Semaglutide |
| VTX3232 30 mg in combination with semaglutideVTX3232 30 mg in combination with semaglutide | Drug | VTX3232 30 mg + Semaglutide |
Primary outcome
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
Time frame: From the first dose of study treatment to Week 16
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.
1 secondary outcome
Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (Hs-CRP) Level
Time frame: From baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Snehal Naik, PhD study director
Zomagen Biosciences Ltd.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VTX3232 30 mg and VTX3232 30 mg in combination with semaglutide in people with Obesity, run by Zomagen Biosciences Ltd. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) (time frame: From the first dose of study treatment to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.