HS235 for Obesity

Overseen By Sarya Aziz, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: 35Pharma Inc

Must not be taking: Weight loss drugs

Disqualifiers: Diabetes, Alcoholism, Drug abuse, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects

Research Team

Monique Champagne, M.Sc.

Principal Investigator

VP, Clinical Operations

Eligibility Criteria

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

Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive

I understand the study and agree to participate.

My weight is 140 kg or less and has been stable.

Exclusion Criteria

I do not have active hepatitis B, C, or HIV.

Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS235

I am taking or have taken drugs that significantly changed my weight.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single ascending dose of HS235 to assess pharmacokinetics, safety, and pharmacodynamics

15 weeks

Multiple visits for blood sampling and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of HS235 to assess pharmacokinetics, safety, and pharmacodynamics

21 weeks

Multiple visits for blood sampling and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HS235

Trial Overview The study is testing HS235 to understand how it's processed in the body (pharmacokinetics), its safety profile, and how it affects the body's response to the drug (pharmacodynamics) compared to a placebo in overweight/obese individuals.

Participant Groups

Group I: Investigational Product Experimental Treatment 1 Intervention

HS235 Subcutaneous Injection

Group II: Placebo Placebo Group 1 Intervention

Subcutaneous Injection

HS235 is already approved in Canada for the following indications:

Approved in Canada as HS235 for:

• None approved yet; Phase 1 clinical trial initiated for cardiometabolic disease and obesity

Who Is Running the Clinical Trial?

35Pharma Inc

Lead Sponsor

Trials

3

Recruited

120+