Testing VTX3232 alone or with semaglutide for obesity treatment

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 is testing if a new drug called VTX3232, alone or with another medication called semaglutide, can help people with obesity lose weight and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zomagen Biosciences Ltd. (Industry-sponsored)
• Locations: 14 sites (Birmingham, Alabama and 13 other locations)
• Trial ID: NCT06771115 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of VTX3232, both alone and in combination with semaglutide, in individuals diagnosed with obesity. Approximately 160 participants will be enrolled and randomly assigned to receive either VTX3232, a placebo, or a combination of VTX3232 and semaglutide over a 12-week double-blind treatment period. The study includes a 30-day screening phase to determine eligibility and a follow-up period of 30 days post-treatment. Participants must meet specific criteria related to body mass index and health history to qualify.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a BMI between 30.0 and 42.0 kg/m2 who have made unsuccessful attempts to lose weight.

Not a fit: Patients with obesity due to endocrinologic disorders or those with a history of diabetes mellitus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals struggling with obesity.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific combination of VTX3232 and semaglutide is relatively novel.

Eligibility 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.

Where this trial is running

Birmingham, Alabama and 13 other locations

• 840005 — Birmingham, Alabama, United States (Recruiting)
• 840003 — Lake Forest, California, United States (Recruiting)
• 840011 — Long Beach, California, United States (Recruiting)
• 840001 — Largo, Florida, United States (Recruiting)
• 840012 — Ocoee, Florida, United States (Recruiting)
• 840016 — Port Orange, Florida, United States (Recruiting)
• 840014 — Newton, Kansas, United States (Recruiting)
• 840015 — Marrero, Louisiana, United States (Recruiting)
• 840017 — Marrero, Louisiana, United States (Recruiting)
• 840002 — Austin, Texas, United States (Recruiting)
• 840006 — Dallas, Texas, United States (Recruiting)
• 840013 — San Antonio, Texas, United States (Recruiting)
• 840018 — San Antonio, Texas, United States (Recruiting)
• 840010 — Waco, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Zomagen Clinical Trial Contact

Conditions Obesity; NLRP3 Inhibitor; VTX3232; Zomagen