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

NCT07579936 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Postmenopausal Women With Osteoporosis

Interventions

DRUG

Intervention Group 3

SAL056 28.2μg administered twice weekly for 8 weeks.

DRUG

SAL056 56.5μg

SAL056 56.5μg administered once weekly for 8 weeks

DRUG

Intervention Group 1

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

DRUG

Intervention Group 2

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

Sponsors & Collaborators

  • Salubris (Suzhou) Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-07-30
Completion
2026-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579936 on ClinicalTrials.gov