NCT03833128

CompletedPhase 1

A Phase 1b Study of the Safety of REN001 in Patients With Fa...

Reneo Pharma Ltd Source

Reneo Pharma Ltd

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

REN001-102

Study Type

interventional

Actual enrollment (reported)

24

Locations

3 countries

Sites

7

Timeline

Study Start

April 4, 2019

Actual (reported)

Primary Completion

January 24, 2022

Actual (reported)

Study Completion

March 21, 2022

Actual (reported)

Brief Summary

The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: March 21, 2022
Actual (reported)
Listed locations: 3 countries · 7 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 4, 2019
Actual (reported)
First Posted
February 6, 2019
Actual (reported)
Study Start
April 4, 2019
Actual (reported)
Primary Completion
January 24, 2022
Actual (reported)
Study Completion
March 21, 2022
Actual (reported)

Last Updated: December 9, 2022
Status Verified: December 2022
Last Update Submitted: December 7, 2022

Conditions

Fatty Acid Oxidation Disorders

Outcome Measures

Primary Outcomes (1)

Adverse Events
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
Continous to Week 12

Study Arms (3)

Group 1 - Part A

EXPERIMENTAL

REN001 Low Dose oral once daily x 12 weeks

Drug: Low Dose REN001

Group 2 - Part A

EXPERIMENTAL

REN001 High Dose oral once daily x 12 weeks

Drug: High Dose REN001

Group 3 - Part B

EXPERIMENTAL

REN001 High Dose oral once daily x 12 weeks

Drug: High Dose REN001

Interventions

Low Dose REN001Drug

Oral

Group 1 - Part A

High Dose REN001Drug

Oral

Group 2 - Part AGroup 3 - Part B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects must give written, signed and dated informed consent
Confirmed diagnosis of FAOD

Sponsors & Collaborators

Reneo Pharma Ltd
Industrylead

Study Sites (7)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Oregon Health and Science University

Portland, Oregon, 97239, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

UT Southwestern Medical Center

Dallas, Texas, 75390-8591, United States

Division of Medical Genetics, University Utah

Salt Lake City, Utah, 84108, United States

Neurology department, Raymond-Poincaré Teaching Hospital, Nord/Est/Ile de France Neuromuscular Reference Center

Garches, 92380, France

Servicio de Neurología - Unidad de Neuromuscular Centro de Referencia Nacional de Enfermedades Neuromusculares raras Instituto de Investigación i+12

Study Officials

Jerry Vockley, M.D., Ph.D.
University of Pittsburgh Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 6, 2019

Study Start

April 4, 2019

Actual (reported)

A diagnostic acylcarnitine profile, in blood or cultured fibroblasts

A stable treatment regimen for at least 30 days prior to enrollment

You may not qualify if:

Unstable or poorly controlled disease
Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer
Have been hospitalized within 3 months prior to screening for any major medical event
Pregnant or nursing females

Contact the study team to confirm eligibility.

Madrid, CP 28041, Spain

Primary Completion

January 24, 2022

Actual (reported)

Study Completion

March 21, 2022

Actual (reported)

Last Updated

December 9, 2022

Record last verified: 2022-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03833128
Data provider: ClinicalTrials.gov
Source updated: 2022-12-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:42 UTC

Locations

ES(1)FR(1)US(5)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Group 1 - Part A

Group 2 - Part A

Group 3 - Part B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations