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New Weight-Loss drug HS235 begins first human tests

NCT ID NCT06714825

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested HS235, an experimental drug, in 39 overweight or obese but otherwise healthy adults. The main goal was to check safety and how the drug behaves in the body, not to measure weight loss. Participants received either HS235 or a placebo as a shot under the skin. Results will help decide if further studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HS235
What this could lead to
If safe and effective, HS235 could become a new option for weight management in people with overweight or obesity.
What could go wrong
This is a very early Phase 1 trial with only 39 people. It is designed to check safety and how the drug moves through the body, not whether it works for weight loss. Many drugs fail at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

39 people

The number who actually took part.

Started

Nov 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female above 40 years of age, inclusive. 2. Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive. 3. Body weight at or below 140 kg with a stable body weight. 4. In good health or with no clinically significant medical conditions 5. Females who are post-menopausal or are of Non-child bearing Potential. 6. Male subjects must be willing not to donate sperm for 90 days after the last dose. 7. Able to understand the study procedures and provide signed informed consent to participate in the study. Exclusion Criteria: 1. Females with a positive pregnancy test or who are lactating. 2. Subjects with diabetes or have previous history of diabetes. 3. Subjects who have recently donated blood, plasma and platelets. 4. Subjects with history of alcoholism or drug abuse. 5. Subjects who received systemic or topical medications, depot injections or implants, hormone replacement, non-prescribed medication or herbal remedies, or daily glucocorticoids for \> 1 month in previous year. 6. Subjects with clinically significant abnormal pulse or blood pressure or temperature. 7. Subjects with a history of a clinically significant medical disorder or lab abnormality. 8. Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS235. 9. Subjects who are carriers of the hepatitis B surface antigen (HBsAg) and are carriers of the hepatitis C antibody (except if Polymerase Chain Reaction Ribonucleic acid (PCR RNA) is negative); or have a positive result to the test for human immunodeficiency virus (HIV) antigen or antibody. 10. Subjects who have, in the opinion of the Investigator, an abnormality in the echocardiogram or 12-lead ECG that put them at increased risk during the study. 11. Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening. 12. Obesity induced by other endocrine disorders. 13. Previous surgical treatment for obesity. 14. Current or history of treatment with medications that may cause significant weight gain or loss.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Syneos Clinical Research Unit

    Québec, Quebec, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.