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

Sponsor
VIVUS LLC
Study ID
NCT07612657
Phase
PHASE3
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • VI-0106 — DRUG
    Tacrolimus Extended-Release Capsules
  • Placebo — DRUG
    Inactive oral capsule

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
May 29, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VI-0106
    Extended-release tacrolimus dosages of 1.25 mg or 0.625 mg oral capsules; once daily; Week 0-24, Week 28-52 during double-blind treatment period; Week 52-104 during open-label treatment period.
  • Placebo Comparator: Placebo
    Placebo oral capsule; once daily; Week 0-52 during double-blind treatment period.

Primary Outcome Measure

Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24 [ Time Frame: Baseline to Week 24 ]

Central Contacts

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