NCT06714825CompletedPhase 1
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects
Phase 1 Single and Multiple Ascending Dose Study in Males and Females Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 27 Nov 2024
- Start date
- 28 Nov 2024
- Primary completion date
- 2 Dec 2025
- Lead sponsor
- 35Pharma Inc., a GSK company
- Diseases
- Obesity
- NCT number
- NCT06714825
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 28 Nov 2024 to the primary completion date, 2 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with diabetes or have previous history of diabetes.
- 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.
- Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening.
- Previous surgical treatment for obesity.
- Current or history of treatment with medications that may cause significant weight gain or loss.
Other illness
- Subjects with history of alcoholism or drug abuse.
- Subjects with a history of a clinically significant medical disorder or lab abnormality.
- Subjects with a significant history of multiple drug allergies, including infusion reactions and hypersensitivity to any of the excipients of HS235.
- 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.
- Obesity induced by other endocrine disorders.
Lab values
- Subjects who have recently donated blood, plasma and platelets.
Other
- Females with a positive pregnancy test or who are lactating.
- Subjects with clinically significant abnormal pulse or blood pressure or temperature.
- 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.
Who the study is looking for
- Male or female above 40 years of age, inclusive.
- Body Mass Index (BMI) between 28 and 40 kg/m2, inclusive.
- Body weight at or below 140 kg with a stable body weight.
- In good health or with no clinically significant medical conditions
- Females who are post-menopausal or are of Non-child bearing Potential.
- Male subjects must be willing not to donate sperm for 90 days after the last dose.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Syneos Clinical Research Unit Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.