CannaLean Completes First-in-Human Study for Oral CBD-Based Dyslipidemia Therapy

CannaLean Completes First-in-Human Study for Oral CBD-Based Dyslipidemia Therapy

By, Admin 21 January 2026

CannaLean Biotechs Ltd., a clinical-stage biotechnology company, announced the successful completion of its first-in-human feasibility study evaluating CLC-01, a patented oral cannabidiol–chitosan formulation for dyslipidemia.

The study assessed safety and early biological activity in adults with elevated LDL cholesterol.

About CLC-01

CLC-01 is CannaLean’s proprietary CBD–chitosan (CBD–CHT) oral formulation, protected by Composition of Matter patents granted in:

  • United States
  • India
  • South Korea
  • Australia

Additional territories are pending.

The formulation combines cannabidiol (CBD) with chitosan, showing superior lipid-lowering activity versus either component alone in multiple preclinical models.

Study execution and collaboration

The feasibility study was conducted in partnership with Clalit Health Services, Israel’s largest healthcare organization.

The trial was executed through Mor Research Applications, Clalit’s commercialization arm and a strategic shareholder in CannaLean.

This collaboration enabled study execution across real-world community clinic settings within Clalit’s nationwide healthcare network.

Study Highlights

Favorable safety profile

CLC-01 was well tolerated across all treated participants. Key safety observations:

  • No serious adverse events reported
  • No clinically meaningful laboratory abnormalities
  • Only mild, transient side effects observed

The results support continued dose optimization and clinical development.

Encouraging lipid-lowering signals

The study showed consistent biological trends favoring CLC-01. Key efficacy observations:

  • Progressive LDL cholesterol reduction during the 12-week treatment phase
  • Continued LDL improvement during the follow-up period
  • ~28% mean reduction in LDL-C by study end compared with controls
  • Total cholesterol levels showed sustained improvement in treated participants

“These first-in-human results validate our platform,” said Prof. Moshe Mittelman, MD, Chief Scientific Officer of CannaLean.
“The safety profile and lipid trends support advancing CLC-01 into larger controlled studies.”

Addressing an unmet dyslipidemia need

Dyslipidemia affects hundreds of millions globally and is a major driver of cardiovascular disease.

Limitations of current treatments include:

  • Incomplete LDL control with statins
  • Tolerability and side-effect concerns
  • High cost or injectable formats for non-statin therapies

CannaLean’s oral CBD-based approach aims to provide a safe, scalable, second-line option suitable for broad patient populations.

Regulatory and market tailwinds

Regulatory momentum in the United States reflects growing acceptance of evidence-based cannabinoid therapies. Key trends include:

  • Progress toward federal cannabis reclassification
  • Public healthcare initiatives evaluating CBD-based treatments

These developments may support regulated clinical pathways for validated cannabinoid platforms.

Next steps

CannaLean plans to advance CLC-01 into a larger, statistically powered clinical program to:

  • Confirm efficacy
  • Support pharmaceutical regulatory development
  • Inform parallel wellness-focused commercialization strategies

About CannaLean Biotechs Ltd.

CannaLean Biotechs Ltd. is a clinical-stage biotechnology company developing CBD-based therapies for metabolic health, supported by strong intellectual property and a strategic partnership with Clalit Health Services.

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