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

Korábbi kezelés

• Have any prior diagnosis of diabetes mellitus
• 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.
• 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.

Más betegség

• Obesity induced by endocrinologic disorders, or diagnosed genetic or syndromic forms of 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.

Laborértékek

• 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.

Egyéb

• Current participation (or within the last 3 months) in an organized weight reduction program.

• 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.