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A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations

NCT07612657 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-29

No results posted yet for this study

Summary

This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.

Conditions

  • Pulmonary Arterial Hypertension
  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
  • Pulmonary Arterial Hypertension PAH
  • Pulmonary Arterial Hypertension WHO Group I

Interventions

DRUG

VI-0106

Tacrolimus Extended-Release Capsules

DRUG

Placebo

Inactive oral capsule

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2028-05-31
Completion
2029-11-30
FDA Drug
Yes

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Diseases

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 NCT07612657 on ClinicalTrials.gov