HS235 for Obesity

No longer recruiting at 1 trial location

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

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. ^{1 2 3 4 5}

Why 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. ^{5 6 7 8 9}

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

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

Obesity induced by other endocrine disorders

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12544978/

SUN-679 HS235, A Novel Lean Mass-Preserving ...

Conclusion: These data demonstrate that HS235 represents a novel approach to treating obesity and associated co-morbidities in a manner that ...

2.

academic.oup.com

academic.oup.com/jes/article/8/Supplement_1/bvae163.017/7812434

8040 Precision-Engineered Activin and GDF Ligand Trap ...

Potent and selective inhibition of activins and GDFs by HS235 represents a novel LBM preserving weight loss strategy orthogonal to incretin mimetics.

3.

ahajournals.org

ahajournals.org/doi/abs/10.1161/circ.152.suppl_3.4366887?af=R

Abstract 4366887: HS235, a Novel Activin Signaling ...

Conclusion: HS235 improved PH, HF, body composition and exercise tolerance in in vivo models. These results demonstrate the differentiated ...

4.

35pharma.com

35pharma.com/news/35pharma-presents-hs235-pre-clinical-heart-failure-and-pulmonary-hypertension-data-in-moderated-poster-session-at-aha-2025

35Pharma Presents HS235 Pre-Clinical Heart Failure and ...

These pre-clinical data highlight HS235's potential to address both cardiopulmonary remodeling as well as metabolic dysfunction that define PH ...

5.

researchgate.net

researchgate.net/publication/374487438_FRI017_Precision-engineered_Activin_And_GDF_Ligand_Trap_HS235_A_Novel_Lean_Mass-preserving_Treatment_for_Obesity

A Novel Lean Mass-preserving Treatment for Obesity

Potent and selective inhibition of activins and GDFs by HS235 represents a novel LBM preserving weight loss strategy.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11453382/

8040 Precision-Engineered Activin and GDF Ligand Trap ...

Collectively, these data support the development of HS235 as a novel anti-obesity agent to complement currently approved incretin-based ...

7.

connect.careboxhealth.com

connect.careboxhealth.com/en-US/trial/listing/560385

Study of HS235 for Assessing the Pharmacokinetics, Safety ...

Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive. Body weight at or below 140 kg with a stable body weight.

8.

diabetesjournals.org

diabetesjournals.org/diabetes/article/73/Supplement_1/298-OR/155362/298-OR-Precision-Engineered-Activin-and-GDF-Ligand

298-OR: Precision-Engineered Activin and GDF Ligand Trap ...

This data supports the development of HS235 as a novel anti-obesity agent to complement currently approved incretin-based medications to ...

9.

35pharma.com

35pharma.com/news/35pharma-announces-oral-presentation-of-hs235-pre-clinical-data-in-obese-hfpef-at-obesityweek-r-2024

35Pharma Announces Oral Presentation of HS235 Pre- ...

35Pharma Announces Oral Presentation of HS235 Pre-Clinical Data in Obese HFpEF at Obesity Week 2024. · decrease in fat mass, including pericardial fat · increase ...