NCT05798923

A Phase 2a Study of LAM-001 for the Treatment of Pulmonary Hypertension

A Phase 2a Single-Arm, Open-Label, Exploratory Study to Assess the Effects of LAM-001 for the Treatment of Pulmonary Hypertension

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OrphAI Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical trial to assess the efficacy and safety of LAM-001 as an add-on therapy for the treatment pulmonary hypertension.

Detailed description

This is a Phase 2a, single-arm, open-label, exploratory study assessing the efficacy and safety of LAM-001 as an add-on therapy for the treatment of WHO functional class III subjects with WSPH Group-1 or Group-3 pulmonary hypertension. Approximately fifteen participants will receive standard of care plus LAM-001 once daily for the first 24 weeks of the study (Core Study). Participants who complete the first 24 weeks on treatment and appear to have a favorable benefit-risk profile will be eligible to continue receiving LAM-001 for the remainder of the study (Extension Period) up to 12 months. All participants will complete evaluations during a Follow-Up Period of 4 weeks.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	LAM-001	LAM-001 administered via dry powder inhalation

Timeline

• Start date: 2023-04-03
• Primary completion: 2025-05-16
• Completion: 2027-09-30
• First posted: 2023-04-05
• Last updated: 2025-06-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study