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

Phase 2

Recruiting

• Conditions: Obesity
• Interventions: Drug: VTX3232 Dose A; Drug: Placebo in combination with semaglutide; Drug: Placebo; Drug: VTX3232 Dose A in combination with semaglutide

• Registration Number: NCT06771115
• Lead Sponsor: Zomagen Biosciences Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VTX3232 Dose A	VTX3232 Dose A	VTX3232 Dose A
Placebo in combination with semaglutide	Placebo in combination with semaglutide	Placebo in combination with semaglutide
Placebo	Placebo	Placebo
VTX3232 Dose A in combination with semaglutide	VTX3232 Dose A in combination with semaglutide	VTX3232 Dose A in combination with semaglutide

Primary Outcome Measures

Name	Time	Method
Incidence Rate and Severity of Adverse Event (AE), Serious Adverse Event (SAE), and AEs leading to study treatment discontinuation through study completion	Day 1 of treatment period through study completion, up to 16 weeks	Incidence of AEs and SAEs and AEs leading to study treatment discontinuation

Secondary Outcome Measures

Name	Time	Method
Change from baseline in hs-CRP level	Day 1 of treatment period to week 12 of treatment period	Change from baseline in hs-CRP through 12 weeks of study treatment

Trial Locations

Locations (14)

840005; 🇺🇸 Birmingham, Alabama, United States

840001; 🇺🇸 Largo, Florida, United States

840012; 🇺🇸 Ocoee, Florida, United States

840016; 🇺🇸 Port Orange, Florida, United States

840014; 🇺🇸 Newton, Kansas, United States

840015; 🇺🇸 Marrero, Louisiana, United States

840017; 🇺🇸 Marrero, Louisiana, United States

840013; 🇺🇸 San Antonio, Texas, United States

840018; 🇺🇸 San Antonio, Texas, United States

840010; 🇺🇸 Waco, Texas, United States

840003; 🇺🇸 Lake Forest, California, United States

840002; 🇺🇸 Austin, Texas, United States

840006; 🇺🇸 Dallas, Texas, United States

840011; 🇺🇸 Long Beach, California, United States