Weight ManagementPhase 1NCT07089823
A Study of YP05002 in Healthy Participants
A Phase 1 study testing YP05002 in people with Weight Management, run by Yaopharma Co., Ltd. at 1 site in Australia.
Trial summary
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management
- What is being tested?
- YP05002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Aug 2025to 13 Mar 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.
- In good health as determined by the Investigator, with no clinically significant findings from medical/psychiatric history, physical examination, 12-lead ECG, vital signs measurements, clinical laboratory evaluations.
Who cannot join
- Have evidence of any clinically significant active or chronic disease.
- Histories of using drug that affect drug absorption, distribution, metabolism, or excretion within 14 days or within 5-half-life prior to the first dose (whichever is longer); gastrointestinal disorders with impaired gastric emptying; or prolonged use of medications that directly modulate gastrointestinal motility.
- Had clinically relevant acute or chronic medical conditions or diseases that would pose a risk to participant's safety or interfere with the study assessments, as determined by the Investigator.
- Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
- Diagnosis of any type of pancreatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YP05002 in Healthy Participants
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants
- Conditions
- Weight Management
- Being tested
- YP05002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YP05002Drug
Tablet, QD
PlaceboOther
Tablet, QD
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | SAD dose 1 Receives: Drug: YP05002; Other: Placebo |
| SAD Cohort 2 | Experimental | SAD dose 2 Receives: Drug: YP05002; Other: Placebo |
| SAD Cohort 3 | Experimental | SAD dose 3 Receives: Drug: YP05002; Other: Placebo |
| SAD Cohort 4 | Experimental | SAD dose 4 Receives: Drug: YP05002; Other: Placebo |
| SAD Cohort 5 | Experimental | SAD dose 5 Receives: Drug: YP05002; Other: Placebo |
| MAD Cohort 1 | Experimental | MAD dose 1 Receives: Drug: YP05002; Other: Placebo |
| MAD Cohort 2 | Experimental | MAD dose 2 Receives: Drug: YP05002; Other: Placebo |
| MAD Cohort 3 | Experimental | MAD dose 3 Receives: Drug: YP05002; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)
Measured: Up to Day 14
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)
Measured: Up to Day 41
Secondary outcomes (2)
Cmax of YP05002 (SAD)
PK parameters of YP05002
Measured: Up to Day 14
Cmax of YP05002 (MAD)
PK parameters of YP05002
Measured: Up to Day 41
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start19 Aug 2025
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089823
- Sponsor's protocol ID
- YP05002-001
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YP05002 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07089823
- Acronym / sponsor ID
- YP05002-001
- Conditions
- Weight Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yaopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 28 Jul 2025 (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.
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of YP05002 Tablets in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: YP05002, Other: PlaceboSAD dose 1 |
| SAD Cohort 2 | Experimental | Drug: YP05002, Other: PlaceboSAD dose 2 |
| SAD Cohort 3 | Experimental | Drug: YP05002, Other: PlaceboSAD dose 3 |
| SAD Cohort 4 | Experimental | Drug: YP05002, Other: PlaceboSAD dose 4 |
| SAD Cohort 5 | Experimental | Drug: YP05002, Other: PlaceboSAD dose 5 |
| MAD Cohort 1 | Experimental | Drug: YP05002, Other: PlaceboMAD dose 1 |
| MAD Cohort 2 | Experimental | Drug: YP05002, Other: PlaceboMAD dose 2 |
| MAD Cohort 3 | Experimental | Drug: YP05002, Other: PlaceboMAD dose 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.
- In good health as determined by the Investigator, with no clinically significant findings from medical/psychiatric history, physical examination, 12-lead ECG, vital signs measurements, clinical laboratory evaluations.
Key exclusion criteria (5 listed)
- Have evidence of any clinically significant active or chronic disease.
- Histories of using drug that affect drug absorption, distribution, metabolism, or excretion within 14 days or within 5-half-life prior to the first dose (whichever is longer); gastrointestinal disorders with impaired gastric emptying; or prolonged use of medications that directly modulate gastrointestinal motility.
- Had clinically relevant acute or chronic medical conditions or diseases that would pose a risk to participant's safety or interfere with the study assessments, as determined by the Investigator.
- Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
- Diagnosis of any type of pancreatitis.
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 |
|---|---|---|
| YP05002Tablet, QD | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
| PlaceboTablet, QD | Other | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4, SAD Cohort 5 |
Primary outcome
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD)
Time frame: Up to Day 14
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (MAD)
Time frame: Up to Day 41
2 secondary outcomes
Cmax of YP05002 (SAD)
Time frame: Up to Day 14
Cmax of YP05002 (MAD)
Time frame: Up to Day 41
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 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 YP05002 in people with Weight Management, run by Yaopharma Co., Ltd. at 1 site in Australia.
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 3 inclusion and 5 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 Jul 2026. 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 Australia. 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. 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?
Number and percentage of adverse events (AEs), serious adverse events (SAEs) in each dose group during the safety observation period (SAD) (time frame: Up to Day 14). The study lists 2 primary outcomes in all. 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 Jul 2026.