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New drug offers hope for Statin-Intolerant patients with high cholesterol

NCT ID NCT05923281

Completed Disease control Sponsor: Kowa Company, Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called pemafibrate (K-877) in 71 people with high cholesterol who cannot take statins due to side effects. Participants took either a low or high dose of pemafibrate or a placebo daily for 12 weeks. The goal was to see if pemafibrate safely lowers LDL (bad) cholesterol.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Pemafibrate (K-877)
What this could lead to
If it works, this could provide a new treatment option for people with high cholesterol who cannot tolerate statins.
What could go wrong
This is a small, completed Phase 3 trial with only 71 participants. The results may not apply to everyone, and pemafibrate may not lower cholesterol as effectively as statins.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HYPERCHOLESTEROLEMIA

Contacts and locations

Locations

  • Affiliated CENTRAL CLINIC of Higashiyamato Hospital

    Tokyo, Japan

  • Central Japan International Medical Center

    Gifu, Japan

  • Fukuwa Clinic

    Tokyo, Japan

  • Juntendo University Hospital

    Tokyo, Japan

  • Kohnodai Hospital, National Center for Global Health and Medicine

    Chiba, Japan

  • Koshigaya Municipal Hospital

    Saitama, Japan

  • Kumamoto University Hospital

    Kumamoto, Japan

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Tokyo, Japan

  • Medical Corporation LONGWOOD Maeda Clinic

    Osaka, Japan

  • Mishuku Hospital

    Tokyo, Japan

  • NTT Medical Center Sapporo

    Hokkaido, Japan

  • Nakayama Clinic

    Aichi, Japan

  • OCROM Clinic

    Osaka, Japan

  • Rinku General Medical Center

    Osaka, Japan

  • Saitama Medical University Hospital

    Saitama, Japan

  • Seiwa Clinic

    Tokyo, Japan

  • Tashiro Endocrinology Clinic

    Fukuoka, Japan

  • ToCROM Clinic

    Tokyo, Japan

  • Tokyo Heart Summit Tokyo Heart Rhythm Hospital

    Tokyo, Japan

  • Tokyo-Eki Center-building Clinic

    Tokyo, Japan

  • Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital

    Ibaraki, Japan

  • Yokohama Minami Kyosai Hospital

    Kanagawa, Japan

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