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

Launched by ZOMAGEN BIOSCIENCES LTD. · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for obesity called VTX3232, both on its own and in combination with another medication called semaglutide. The main goal is to see if these treatments are safe for people with obesity. About 160 participants will take part in the study, which will last for a total of 12 weeks. During this time, some participants will receive VTX3232, others will receive a placebo (a treatment that looks like the real drug but has no active ingredients), and some will receive a combination of VTX3232 and semaglutide.

To be eligible for the study, participants must be between 18 and 80 years old, have a body mass index (BMI) of 30 or higher, and have been stable in weight for the last three months. They should also have a history of trying to lose weight without success. However, individuals with certain medical conditions, recent weight loss program participation, or specific medications may not qualify. The study involves a screening phase to check eligibility, a treatment phase where participants will not know which treatment they are receiving (this is called a double-blind study), and a follow-up phase after the treatment ends. It's an important step in understanding how these treatments could help people struggling with obesity.

Gender

ALL

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.