Drug-induced Weight GainPhase 1NCT05857566

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

A Phase 1 study testing RDX-002 + Olanzipine and Olanzapine in people with Drug-induced Weight Gain, run by Response Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Drug-induced Weight Gain
What is being tested?: RDX-002 + Olanzipine and Olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 16 May 2023to 13 Sep 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 21Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Nucleus Network
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A Randomized, Open-Label Study of the Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With the Atypical Antipsychotic Drug, Olanzapine

Read the 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.

Conditions: Drug-induced Weight Gain
Being tested: RDX-002 + Olanzipine, Olanzapine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDX-002 + OlanzipineDrug
A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.
OlanzapineDrug
An FDA-approved atypical (second-generation) antipsychotic medication

Study groups in NCT05857566
Study group	Role	What they receive
RDX-002 + Olanzapine	Experimental	RDX-002: 50 mg oral tablet; 200 mg BID for 7 days Olanzapine: 10 mg oral tablet; 10 mg QD for 7 days Receives: Drug: RDX-002 + Olanzipine
Olanzapine	Other	10 mg oral tablet; 10 mg QD for 14 days Receives: Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute Area Under the Curve (AUC) on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean percent difference between the two treatment arms for postprandial triglyceride absolute area under the curve (AUC) on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days
Mean Absolute Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute AUC on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean absolute difference between the two treatment arms for postprandial triglyceride absolute AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days
Mean Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Incremental AUC on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean percent difference between the two treatment arms for postprandial triglyceride incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days
Mean Absolute Difference Between the Two Treatment Arms for Postprandial Triglyceride Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean absolute difference between the two treatment arms for postprandial triglyceride incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days

Secondary outcomes (4)

Mean Percent Difference Between the Two Treatment Arms for Postprandial ApoB48 AUC on Day 15 as Compared to Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean percent difference between the two treatment arms for postprandial ApoB48 AUC on Day 15 as compared to Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days
Mean Absolute Difference Between the Two Treatment Arms for Postprandial ApoB48 AUC on Day 15 as Compared to Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean absolute difference between the two treatment arms for postprandial ApoB48 AUC on Day 15 as compared to Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days
Mean Percent Difference Between the Two Treatment Arms for Postprandial ApoB48 Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean percent difference between the two treatment arms for postprandial ApoB48 incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days
Mean Absolute Difference Between the Two Treatment Arms for Postprandial ApoB48 Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
The mean absolute difference between the two treatment arms for postprandial ApoB48 incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 202313 Sep 2023

First posted12 May 2023
Study start16 May 2023
Primary completion13 Jul 2023
Study completion13 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Drug-induced Weight GainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Phase 1b, randomized, open-label, parallel group study
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05857566
Sponsor's protocol ID: RDX-002-22-09
Status last verified: Aug 2026
First submitted: 28 Apr 2023
Last updated: 2 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No sharing of IPD with other researchers.

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label Study of the Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With the Atypical Antipsychotic Drug, Olanzapine
ClinicalTrials.gov ID: NCT05857566
Acronym / sponsor ID: RDX-002-22-09
Conditions: Drug-induced Weight Gain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Response PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 16 May 2023 (actual)
Primary completion: 13 Jul 2023 (actual)
Study completion: 13 Sep 2023 (actual)
First posted: 12 May 2023 (actual)
Results: Posted 2 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Phase 1b, randomized, open-label, parallel group study

Arm	Type	Receives
RDX-002 + Olanzapine	Experimental	Drug: RDX-002 + OlanzipineRDX-002: 50 mg oral tablet; 200 mg BID for 7 days Olanzapine: 10 mg oral tablet; 10 mg QD for 7 days
Olanzapine	Other	Drug: Olanzapine10 mg oral tablet; 10 mg QD for 14 days

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RDX-002 + OlanzipineA potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.	Drug	RDX-002 + Olanzapine
OlanzapineAn FDA-approved atypical (second-generation) antipsychotic medication	Drug	Olanzapine

Primary outcome

Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute Area Under the Curve (AUC) on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
The mean percent difference between the two treatment arms for postprandial triglyceride absolute area under the curve (AUC) on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Mean Absolute Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute AUC on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
The mean absolute difference between the two treatment arms for postprandial triglyceride absolute AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Mean Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Incremental AUC on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
The mean percent difference between the two treatment arms for postprandial triglyceride incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose
Mean Absolute Difference Between the Two Treatment Arms for Postprandial Triglyceride Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
The mean absolute difference between the two treatment arms for postprandial triglyceride incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 hours post dose

4 secondary outcomes

Mean Percent Difference Between the Two Treatment Arms for Postprandial ApoB48 AUC on Day 15 as Compared to Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
Mean Absolute Difference Between the Two Treatment Arms for Postprandial ApoB48 AUC on Day 15 as Compared to Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
Mean Percent Difference Between the Two Treatment Arms for Postprandial ApoB48 Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days
Mean Absolute Difference Between the Two Treatment Arms for Postprandial ApoB48 Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose
Time frame: 7 days

Results and safety

Results posted to the registry on 2 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RDX-002 + Olanzapine	16	13
Olanzapine	8	7

Primary outcome: Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute Area Under the Curve (AUC) on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose

Time frame: 7 days. Mean (Full Range). Unit: Percent change

Measure	RDX-002 + Olanzapine n = 13	Olanzapine n = 7
Value	-29.3 (-58.2 to -3.0)	-3.24 (-44.1 to 60.9)

Primary outcome: Mean Absolute Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute AUC on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose

Time frame: 7 days. Mean (Full Range). Unit: mg*hr/dL

Measure	RDX-002 + Olanzapine n = 13	Olanzapine n = 7
Value	-631.5 (-3279.5 to -27.0)	-126.5 (-827.3 to 486.0)

Primary outcome: Mean Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Incremental AUC on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose

Time frame: 7 days. Mean (Full Range). Unit: Percent change

Measure	RDX-002 + Olanzapine n = 13	Olanzapine n = 7
Value	-81.5 (-204.9 to -29.7)	-18.79 (-61.8 to 72.7)

Primary outcome: Mean Absolute Difference Between the Two Treatment Arms for Postprandial Triglyceride Incremental AUC on Day 15 vs. Day 8: 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose

Time frame: 7 days. Mean (Full Range). Unit: mg*hr/dL

Measure	RDX-002 + Olanzapine n = 13	Olanzapine n = 7
Value	-621.0 (-2143.5 to -148.5)	-164.8 (-615.3 to 318.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RDX-002 + Olanzapine	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16
Olanzapine	0 of 8 (0%)	8 of 8 (100%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No sharing of IPD with other researchers.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tricia Stamp, PhD, PA-C principal investigator

Nucleus Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RDX-002 + Olanzipine and Olanzapine in people with Drug-induced Weight Gain, run by Response Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Difference Between the Two Treatment Arms for Postprandial Triglyceride Absolute Area Under the Curve (AUC) on Day 15 vs. Day : 0, 1, 2, 3, 4, 6, and 8 Hours Post Dose (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05857566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.