A Placebo-controlled Study of Volixibat in Subjects With Elevated Serum Bile Acids Associated With Intrahepatic Cholestasis of Pregnancy (OHANA)

(OHANA Trial)

Recruiting at 27 trial locations

Overseen By Clinical Trials Mirum

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Mirum Pharmaceuticals, Inc.

Disqualifiers: Non-reassuring fetal status, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

4 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What makes the drug Volixibat unique compared to other treatments?

Volixibat is unique because it targets bile acid transporters in the gut, which can help reduce bile acid levels and improve liver function, offering a novel approach compared to traditional treatments that may not focus on bile acid modulation. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing volixibat, a medication for pregnant women with a liver condition that causes high bile acid levels. The medication aims to lower these levels to reduce symptoms and risks.

Eligibility Criteria

Inclusion Criteria

Provide signed informed consent as described in the protocol and willing to comply with all study visits and requirements.

Diagnosis of ICP.

(Part 2 only) Qualified level of pruritus associated with ICP, during screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Open-label randomized study of volixibat to evaluate safety and tolerability of two doses

Up to 21 weeks

Treatment Part 2

Double-blind, placebo-controlled study to evaluate the safety and efficacy of a selected volixibat dose

Up to 21 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Volixibat

Participant Groups

Group I: Part 2 Arm 1 - Volixibat Selected Dose mg Experimental Treatment 2 Interventions

Participants randomized to this arm will receive volixibat selected dose (mg) twice daily.

Group II: Part 1 Arm 2 - Volixibat 80mg Experimental Treatment 1 Intervention

Participants randomized to this arm will receive volixibat 80mg twice daily.

Group III: Part 1 Arm 1 - Volixibat 20mg Experimental Treatment 1 Intervention

Participants randomized to this arm will receive volixibat 20mg twice daily.

Group IV: Part 2 Arm 2 - Placebo (Placebo Comparator) Placebo Group 1 Intervention

Participants in this arm will receive capsules matched to the study drug minus the active volixibat substance, twice daily.

Who Is Running the Clinical Trial?

Mirum Pharmaceuticals, Inc.

Lead Sponsor

Trials

32

Recruited

102,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

CL-705G: a novel chemical Kir6.2-specific KATP channel opener. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Kalium 2.0, a comprehensive database of polypeptide ligands of potassium channels. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Insulinotropic action of (2S)-2-benzyl-3-(cis-hexahydro-2-isoindolinylcarbonyl) propionate. I. Secretory and cationic aspects. [2019]

4. England pubmed.ncbi.nlm.nih.gov

VU0810464, a non-urea G protein-gated inwardly rectifying K+ (Kir 3/GIRK) channel activator, exhibits enhanced selectivity for neuronal Kir 3 channels and reduces stress-induced hyperthermia in mice. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The effects of cromakalim on the detrusor muscle of human and pig urinary bladder. [2019]