RecruitingPhase 2NCT07579936

A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens

Evaluation of the Safety and Efficacy of SAL056 (Recombinant Human Parathyroid Hormone [1-34] for Injection [56.5 μg]) at Different Doses and Dosing Regimens: A Multicenter, Randomized, Open-Label, Parallel-Controlled Phase II Clinical Trial

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Enrollment

200 participants

Start Date

Apr 30, 2026

Study Type

INTERVENTIONAL

Conditions

postmenopausal women with osteoporosis

Summary

This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.

Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intervention Group 1, a drug called Intervention Group 2, and others for people with postmenopausal women with osteoporosis. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 45 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSAL056 56.5μg

SAL056 56.5μg administered once weekly for 8 weeks

DRUGIntervention Group 1

Teriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks.

DRUGIntervention Group 2

Teriparatide Injection daily formulation administered for 4 weeks, followed by SAL056 for 4 weeks.

DRUGIntervention Group 3

SAL056 28.2μg administered twice weekly for 8 weeks.

Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07579936