VTX3232 and Semaglutide for Obesity Safety Evaluation
VTX3232 Dose A
+ Placebo
+ VTX3232 Dose A in combination with semaglutide
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: January 7, 2025
Actual date on which the first participant was enrolled.The study is focused on understanding the safety of the drug VTX3232, whether used alone or together with another medication called semaglutide, in people who are diagnosed with obesity. This research involves approximately 160 participants who will be randomly assigned to receive either VTX3232, a placebo (a substance with no active drug), VTX3232 combined with semaglutide, or a placebo combined with semaglutide. The importance of this study lies in potentially finding new effective treatment options for obesity, a condition that can lead to various health issues. Participants in the study will first go through a 30-day screening period to determine if they qualify for the study. Those who qualify will then undergo a 12-week treatment phase where they receive one of the four potential treatments in a double-blind fashion, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo. After the treatment phase, participants will have a 30-day follow-up period. The study aims to measure the safety and tolerability of these treatments, alongside understanding how the body processes the drug and its effects, helping to gather valuable information about potential new treatments for obesity.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.176 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
840003
Lake Forest, United States840011
Long Beach, United States840001
Largo, United States