A clinical-stage biotechnology company developing a cannabidiol-based treatment for high cholesterol says it has successfully completed its first human study, reporting both a favorable safety profile and early signals of reduced LDL cholesterol.
CannaLean Biotechs announced this week that it has finished a first-in-human feasibility study of CLC-01, an oral formulation that combines cannabidiol, or CBD, with chitosan. The study evaluated safety and early biological activity in adults with elevated LDL cholesterol, commonly referred to as “bad” cholesterol.
According to the company, the 12-week study found that CLC-01 was well tolerated among all participants. No serious adverse events or clinically meaningful laboratory abnormalities were reported, with only mild and temporary side effects observed during the trial period.
In addition to safety findings, the company reported encouraging lipid-related trends. Participants who received CLC-01 experienced a gradual reduction in LDL cholesterol throughout the treatment phase, with continued improvement during follow-up. By the end of the study period, average LDL cholesterol levels among treated participants declined by about 28% compared with the control group. Total cholesterol levels followed a similar pattern, with sustained reductions reported in the treatment arm.
“These first-in-human results provide an important validation of our platform,” said Professor Moshe Mittelman, MD, CannaLean’s chief scientific officer. “The favorable safety profile and consistent lipid trends support advancing CLC-01 into larger, controlled clinical studies.”
The study was conducted in collaboration with Clalit Health Services, Israel’s largest healthcare organization, through its research and commercialization arm, Mor Research Applications. The partnership allowed the trial to be carried out across Clalit’s nationwide network of community clinics.
CannaLean says dyslipidemia continues to affect hundreds of millions of people worldwide, with many patients unable to tolerate statins or achieve target cholesterol levels. The company plans to move CLC-01 into a larger, statistically powered clinical program to further evaluate its effectiveness and support continued pharmaceutical development.
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