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Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis

NCT04521114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-03-01

Study results available
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Summary

This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).

Conditions

  • Nonalcoholic Steatohepatitis (NASH)

Interventions

DRUG

Placebo

Placebo will be administered subcutaneously every week for 13 weeks.

DRUG

leronlimab 700 mg

700 mg leronlimab will be administered subcutaneously every week for 13 weeks.

DRUG

leronlimab 350 mg

350 mg leronlimab will be administered subcutaneously every week for 13 weeks.

Sponsors & Collaborators

  • CytoDyn, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-29
Completion
2021-12-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521114 on ClinicalTrials.gov