Clinical trial NCT06771115: Phase 2a Placebo-Controlled Study of VTX3232 Alone or in Combination With Semaglutide in Obesity
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Keywords: NLRP3 Inhibitor
VTX3232
Zomagen
Lead sponsor: Zomagen Biosciences Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Incidence Rate and Severity of Adverse Event (AE), Serious Adverse Event (SAE), and AEs leading to study treatment discontinuation through study completion
timeFrame: Day 1 of treatment period through study completion, up to 16 weeks
Secondary outcomes:
measure: Change from baseline in hs-CRP level
timeFrame: Day 1 of treatment period to week 12 of treatment period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 840005
state: Alabama
city: Lake Forest
country: United States
facility: 840003
state: California
city: Long Beach
country: United States
facility: 840011
state: California
city: Largo
country: United States
facility: 840001
state: Florida
city: Ocoee
country: United States
facility: 840012
state: Florida
city: Port Orange
country: United States
facility: 840016
state: Florida
city: Newton
country: United States
facility: 840014
state: Kansas
city: Marrero
country: United States
facility: 840015
state: Louisiana
city: Marrero
country: United States
facility: 840017
state: Louisiana
city: Austin
country: United States
facility: 840002
state: Texas
city: Dallas
country: United States
facility: 840006
state: Texas
city: San Antonio
country: United States
facility: 840013
state: Texas
city: San Antonio
country: United States
facility: 840018
state: Texas
city: Waco
country: United States
facility: 840010
state: Texas
Study officials:
affiliation: Zomagen Biosciences Ltd.
name: Snehal Naik, PhD
role: STUDY_DIRECTOR
References: