HS235 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called HS235 to evaluate its effects on individuals who are overweight or obese. Researchers aim to learn more about the drug's safety and its behavior in the body. Participants will receive either the HS235 injection or a placebo (a harmless substance with no treatment effect) for comparison. The trial seeks individuals over 40 with a stable body weight and a BMI between 28 and 40 who are otherwise healthy and not diabetic. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects on people.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes those who have used certain medications that affect weight within the last 3 months. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that HS235 is likely to be safe for humans?
A previous study tested HS235 as a treatment for obesity and showed promising results. Early research indicates that HS235 can reduce fat, including fat around the heart. While these findings are encouraging, the current study is in an early stage, focusing mainly on the safety of HS235 for humans and how the body processes it.
In these early studies, researchers closely monitor side effects and treatment tolerance. Specific information on side effects is not yet available, but since the trial is in an early phase, it primarily aims to assess safety. Researchers continue to collect information to ensure HS235 is safe for humans. More data from ongoing studies will help clarify its safety profile.12345Why do researchers think this study treatment might be promising for obesity?
HS235 is unique because it is administered as a subcutaneous injection specifically targeting obesity, which is different from many current options like oral medications or lifestyle modifications. Researchers are excited about HS235 because it potentially offers a new mechanism of action, possibly engaging biological pathways not addressed by existing treatments. This could mean more effective weight management for patients who haven't had success with traditional methods.
What evidence suggests that HS235 might be an effective treatment for obesity?
Research has shown that HS235, which participants in this trial may receive, is a promising new treatment for obesity. It blocks certain proteins that affect weight, aiding in weight loss while preserving muscle. In animal studies, HS235 improved body shape and exercise ability. These early findings suggest HS235 could effectively manage weight.56789
Who Is on the Research Team?
Monique Champagne, M.Sc.
Principal Investigator
VP, Clinical Operations
Are You a Good Fit for This Trial?
This trial is for overweight or obese individuals who are generally healthy. Specific eligibility criteria details are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions, medications they're taking, or their history with similar treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single ascending dose of HS235 to assess pharmacokinetics, safety, and pharmacodynamics
Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses of HS235 to assess pharmacokinetics, safety, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HS235
HS235 is already approved in Canada for the following indications:
- None approved yet; Phase 1 clinical trial initiated for cardiometabolic disease and obesity
Find a Clinic Near You
Who Is Running the Clinical Trial?
35Pharma Inc
Lead Sponsor