Overweight and ObesityPhase 1NCT06714825
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics in Overweight/Obese Healthy Subjects
A Phase 1 study testing HS235 in people with Overweight and Obesity, run by 35Pharma Inc., a GSK company at 1 site in Canada.
Trial summary
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- HS235
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2024to 2 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Females with a positive pregnancy test or who are lactating.
- Subjects with diabetes or have previous history of diabetes.
- Subjects who have recently donated blood, plasma and platelets.
- Subjects with history of alcoholism or drug abuse.
- 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.
- Subjects with clinically significant abnormal pulse or blood pressure or temperature.
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- 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.
- 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.
- Current or history of treatment with medications that may cause significant weight gain or loss, within 3 months or 5 half-lives of screening.
- Obesity induced by other endocrine disorders.
- Previous surgical treatment for obesity.
- Current or history of treatment with medications that may cause significant weight gain or loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
Read the detailed description
A Phase 1 Study Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects: Single Ascending Dose (SAD) in Males and Postmenopausal Females and Multiple Ascending Dose (MAD) in Males and Females of Non-childbearing Potential
- Conditions
- Overweight and Obesity
- Being tested
- HS235, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS235Biological
Up to 4 Single and 3 Multiple Ascending Doses
PlaceboDrug
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | HS235 Subcutaneous Injection Receives: Biological: HS235 |
| Placebo | Placebo comparator | Subcutaneous Injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Number of Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.The incidence and number of patients who experience an AE will be reported.
Measured: up to 106 days for Single dose and 147 days for multiple doses
Secondary outcomes (4)
Area under concentration time curve (AUC) zero to t
Blood samples will be collected to determine the Area under the concentration-time curve from time zero until the last observed concentration
Measured: up to 106 days for Single dose and 147 days for multiple doses
Area under concentration time curve (AUC) zero-infinity
Blood samples will be collected to determine the Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: up to 106 days for Single dose and 147 days for multiple doses
Maximum observed Plasma Concentration (Cmax)
Blood samples will be collected to determine Cmax
Measured: up to 106 days for Single dose and 147 days for multiple doses
Time to maximum concentration (Tmax)
Blood samples will be collected to determine Tmax
Measured: up to 106 days for Single dose and 147 days for multiple doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start28 Nov 2024
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- 35Pharma Inc., a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monique Champagne, M.Sc., Study director, VP, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714825
- Sponsor's protocol ID
- HS235-001
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06714825
- Acronym / sponsor ID
- HS235-001
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- 35Pharma Inc., a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of HS235 for Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects
Detailed description
A Phase 1 Study Assessing the Pharmacokinetics, Safety, and Pharmacodynamics of HS235 in Overweight and Obese Otherwise Healthy Subjects: Single Ascending Dose (SAD) in Males and Postmenopausal Females and Multiple Ascending Dose (MAD) in Males and Females of Non-childbearing Potential
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Biological: HS235HS235 Subcutaneous Injection |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous Injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- Females with a positive pregnancy test or who are lactating.
- Subjects with diabetes or have previous history of diabetes.
- Subjects who have recently donated blood, plasma and platelets.
- Subjects with history of alcoholism or drug abuse.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS235Up to 4 Single and 3 Multiple Ascending Doses | Biological | Investigational Product |
| PlaceboSubcutaneous Injection | Drug | Placebo |
Primary outcome
Incidence and Number of Adverse Events (AEs)
Time frame: up to 106 days for Single dose and 147 days for multiple doses
An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.The incidence and number of patients who experience an AE will be reported.
4 secondary outcomes
Area under concentration time curve (AUC) zero to t
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Area under concentration time curve (AUC) zero-infinity
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Maximum observed Plasma Concentration (Cmax)
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Time to maximum concentration (Tmax)
Time frame: up to 106 days for Single dose and 147 days for multiple doses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique Champagne, M.Sc. study director
VP, Clinical Operations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS235 in people with Overweight and Obesity, run by 35Pharma Inc., a GSK company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Number of Adverse Events (AEs) (time frame: up to 106 days for Single dose and 147 days for multiple doses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.