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

Zomagen Biosciences Ltd.

Status and phase: Enrolling; Phase 2

Conditions: Obesity

Treatments: Drug: VTX3232 Dose A; Drug: Placebo in combination with semaglutide; Drug: Placebo; Drug: VTX3232 Dose A in combination with semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06771115

VTX3232-204

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

VTX3232 Dose A

Experimental group

Description:

VTX3232 Dose A

Treatment:

Drug: VTX3232 Dose A

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

VTX3232 Dose A in combination with semaglutide

Experimental group

Description:

VTX3232 Dose A in combination with semaglutide

Treatment:

Drug: VTX3232 Dose A in combination with semaglutide

Placebo in combination with semaglutide

Experimental group

Description:

Placebo in combination with semaglutide

Treatment:

Drug: Placebo in combination with semaglutide