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LAM-001

Phase 2

Pulmonary Hypertension Due to Lung Diseases and Hypoxia | Small molecule | Cardiovascular |cbdMD, Inc.|Last Updated: Aug 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

LAM-001 · 1 trial · 1 indication

Phase 2 1
NCT05798923LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RECRUITING85 Analytics
PHASE2RECRUITING
LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
NCT0579892385
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Study Endpoints

Primary Endpoints

To determine the change in PVR at 24 weeks
24 weeks

Change in PVR at 24 weeks

Secondary Endpoints

To assess the effect of LAM-001 as an add-on therapy in adults with PH-ILD on exercise tolerance as assessed by the placebo-corrected change in 6MWD after 24 weeks
24 weeks
To assess the effect of LAM-001 on Clinical Worsening at 24 weeks
24 weeks
To assess the effect of LAM-001 as measured by change from baseline in WHO Functional Class at 24 weeks
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Matched PlaceboPLACEBO_COMPARATORPlacebo (1 or 2 oral inhalations) administered once daily via a Dry Powder Inhaler (DPI)
LAM-001 - High DoseACTIVE_COMPARATORLAM-001 (2, 100 mcg oral inhalations) once daily via a Dry Powder Inhaler (DPI)
LAM-001 - Low DoseACTIVE_COMPARATORLAM-001 (1, 100 mcg oral inhalation) once daily via a Dry Powder Inhaler (DPI)

Interventions

NameTypeDescription
PlaceboDRUGMatching placebo administered via dry powder inhalation
LAM-001DRUGLAM-001 administered via dry powder inhaler
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Age 18-80 years (\>70 y/o requires medical monitor approval) 2. Diagnosis of PH-ILD as defined by CT imaging within 1 year of screening that demonstrates diffuse parenchymal lung disease or abnormal PFTs (see IC #3) associated with one of the following: 1. Idiopathic inte...

Countries:United States
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Frequently asked questions about LAM-001

What is LAM-001 used for?

LAM-001 is an investigational small molecule being developed for the treatment of pulmonary hypertension due to lung diseases and hypoxia. It is specifically being studied in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug is currently in Phase 2 clinical development.

Who is developing LAM-001?

LAM-001 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials for this investigational drug in the United States.

What phase is LAM-001 in?

LAM-001 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants in the United States.

What clinical trials is LAM-001 in?

LAM-001 is being studied in a Phase 2 clinical trial registered as NCT05798923. This trial is titled "LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)" and is currently recruiting participants in the United States. The trial is randomized, double-blind, and placebo-controlled, with an enrollment target of 85 patients.

Is LAM-001 being studied in a randomized controlled trial?

Yes, LAM-001 is being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial. This trial design helps assess the drug's efficacy and safety compared to placebo in patients with pulmonary hypertension associated with interstitial lung disease.

What is the enrollment and design of the LAM-001 trial?

The Phase 2 trial for LAM-001 (NCT05798923) has a planned enrollment of 85 participants. It is a randomized, double-blind, placebo-controlled study that includes biomarker selection. The trial is open to adults aged 18 years and older of all sexes, and it is being conducted in the United States.