YP05002 tablets for weight management in healthy adults

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 phase 1 trial will test YP05002 tablets in healthy adults to see if they are safe, well tolerated, how the drug behaves in the body, and whether food changes its effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Yaopharma Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07089823 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled single and multiple ascending dose phase 1 trial in healthy adults. Participants will receive either YP05002 or placebo under blinded conditions to characterize safety, tolerability, and pharmacokinetics. The study also includes a food-effect assessment to see how meals alter YP05002 absorption. Data from this trial will guide dosing and design of later efficacy trials for weight-management indications.

Who should consider this trial

Good fit: Healthy adults aged 18 to 65 who are in good health with no clinically significant medical or psychiatric conditions and who can comply with all study visits and tests are eligible.

Not a fit: People with active or chronic medical conditions, significant gastrointestinal disorders, or recent use of drugs that affect absorption or metabolism are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify a safe dose and dosing schedule for YP05002 that may lead to a new weight-management treatment option.

How similar studies have performed: This is an early-phase first-in-human style study; prior phase 1 trials of other weight-management compounds have helped establish dosing and safety but do not guarantee later clinical benefit.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
2. Healthy male and female participants aged 18-65 years (both inclusive).No restrictions on race.
3. 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.

Exclusion Criteria:

1. Have evidence of any clinically significant active or chronic disease.
2. 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.
3. 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.
4. Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
5. Diagnosis of any type of pancreatitis.

Where this trial is running

Melbourne, Victoria

• Nucleus Network Melbourne Clinic — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Yalei Xie

Conditions Weight Management