Effect of RDX-002 on Postprandial Triglycerides in Subjec... | NCT05857566

Studies
Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine

NCT05857566

Sponsor

Response Pharmaceuticals

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Drug-induced Weight Gain

Interventions

RDX-002

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2023Actual

Primary Completion Date

Jul 13, 2023Actual

Completion Date

Sep 13, 2023Actual

First Submitted Date

Apr 28, 2023

First Submission Date that Met QC Criteria

May 11, 2023

First Posted Date

May 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine. It is a randomized, open-label, parallel group study that will be conducted at a single study site in the US. Normal, healthy subjects aged 18-50 years and with a body mass index (BMI) of 18-27.5 kg/m2 will be eligible for screening. Screening (Day -28) will begin approximately 28 days prior to Baseline (Day 1). Subjects will be admitted to the clinical research unit (CRU) on the morning of Day -1 and will remain in the CRU until discharge on Day 16.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RDX-002	Experimental	50 mg oral tablet; 200 mg BID for 7 days	Drug: RDX-002
Olanzapine	Other	10 mg oral tablet; 10 mg QD for 14 days	Drug: RDX-002

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RDX-002	Drug	A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.	Olanzapine RDX-002

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Triglyceride and apolipoprotein B48 (ApoB48)	Efficacy of treatment with RDX-002 on postprandial triglyceride levels and apolipoprotein B48 (ApoB48) levels in normal healthy volunteers treated with 10 mg olanzapine.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Triglyceride Level	Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers	7 days
Cmax	Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A glycated hemoglobin (HbA1c) level of <5.7% at Screening
A 12-lead electrocardiogram (ECG) at Screening which, in the opinion of the Investigator, had no abnormalities that compromised safety in this study
Hematology, clinical chemistry and urinalysis at Screening, the results of which fall within normal parameter ranges and/or are deemed clinically acceptable by the Investigator Exclusion Criteria
Males and nonpregnant, nonlactating females

Exclusion Criteria:

Any prior use of or contraindication to atypical antipsychotics
Concomitant use of drugs known to impact the PK of olanzapine
Type 1 or Type 2 diabetes
Recent CV event
Uncontrolled hypertension
Fasting triglycerides ≥400 mg/dL
Fasting glucose ≥100 mg/dL
Any condition that impacts the absorption of dietary fats
Significant gastrointestinal disorders
Gall bladder disease
Uncontrolled hypothyroidism
Liver disease or dysfunction
Renal disease or dysfunction
Gastrointestinal conditions
Hematologic disorders
Active malignancy
Psychiatric disorder
History of drug or alcohol abuse
Pregnant, breastfeeding, or intending to become pregnant
Use of weight loss products
Blood donation or loss within 30 days prior to Screening

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Tricia Stamp, PhD, PA-C	Nucleus Network	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network		Saint Paul	Minnesota	55114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No sharing of IPD with other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 5, 2025
Reset	Dec 19, 2025
Release	Apr 21, 2026
Reset	May 12, 2026

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 5, 2025			Dec 19, 2025
Apr 21, 2026