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

Zomagen Biosciences Ltd.

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: VTX3232 30 mg in combination with semaglutide; Drug: VTX3232 30 mg; Drug: Placebo in combination with semaglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06771115

J7V-MC-EOBA (Other Identifier)

VTX3232-204

Details and patient eligibility

About

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.

Enrollment: 175 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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175 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo orally once daily for 12 weeks and were followed for 30 days after the last dose.

Treatment:

Drug: Placebo

VTX3232 30 mg

Experimental group

Description:

Participants received VTX3232 30 milligrams (mg) orally once daily for 12 weeks and were followed for 30 days after the last dose.

Treatment:

Drug: VTX3232 30 mg

Placebo + Semaglutide

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo in combination with semaglutide

VTX3232 30 mg + Semaglutide

Experimental group

Description:

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.

Treatment:

Drug: VTX3232 30 mg in combination with semaglutide