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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06771115

Run by

Zomagen Biosciences Ltd.

People needed

176

Starts

2025-01-07

Expected to finish

2025-09-10

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Any immunosuppressive biologic or targeted therapy within 90 days prior to Day 1.
• Use of anti-inflammatory medications within 30 days prior to Day 1
• Colchicine within 30 days prior to Day 1.
• Glucose-lowering agent(s) administered for conditions other than diabetes within 90 days before screening.

Where it is running

• 840005 — Birmingham, Alabama, United States
• 840003 — Lake Forest, California, United States
• 840011 — Long Beach, California, 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
• 840002 — Austin, Texas, United States
• 840006 — Dallas, Texas, United States
• 840013 — San Antonio, Texas, United States
• 840018 — San Antonio, Texas, United States
• 840010 — Waco, Texas, United States

Full record on ClinicalTrials.gov

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