HypercholesterolemiaPhase 1NCT04927221

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability of DC371739 Treatment in Hypercholesterolemic

A Phase 1 study testing DC371739 Tablets in people with Hypercholesterolemia, run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.

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

This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to initially explore the efficacy and safety in hypercholesterolemia subjects. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: DC371739 Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteChina
Study dates: 1 Apr 2021to 21 Dec 2021
Phase: Phase 1
Are there results?: None posted in the registry

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women aged 18 to 65 years (inclusive 18 and 65);
Body mass index of 18 to 32 kg/m2(inclusive);
Hypercholesterolemia subjects with LDL-C≥2.6mmol/L(100mg/dL);
Male or female subjects who had no immediate plans to have children, the serum pregnancy test of women was negative at the time of screening, and agreed to use strict contraceptive measures throughout the study period and up to 6 months after the last dose;

Who cannot join

ECG confirmed that the QT interval was prolonged > 450ms (QT interval corrected for heart rate by Bazetts formula [QTCB]);
Use of statins (lovastatin, simvastatin, pravastatin, mevastatin, fluvastatin, atorvastatin, cerivastatin, rosuvastatin, pitavastatin, etc.) , ezetimibe, Xuezhikan, and other lipid-lowering treatment within 2 months prior to screening; use of PCSK9 monoclonal antibodies , fibric acid drugs (such as fenofibrate, gemfibrozil) and probucol within 3 months prior to screening;
Use of warfarin, systemic steroids, cyclosporine, or other immunosuppressive therapy within months prior to screening;
Subjects with HIV-AB , HBsAg, ANTI-TP , HCV-AB positive;
A history of prescription drug abuse and illicit drug abuse within 6 months prior to screening;
A history of alcohol abuse within 6 months prior to screening;

Trial locations and contacts

1 site in 1 country.

China1 site

The First Hospital of Jilin University
Changchun, Jilin

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DC739 Multiple-Dose in Hypercholesterolemic Subjects.

Read the detailed description

Totally about 30-50 qualified subjects were assigned to one of the following dose groups：20mg, 40mg, 60mg, 80mg, 120 mg (60mg and 120mg is the optional dose group). Each of the dose groups will include 10 subjects (8 for DC739 and 2 for placebo).

Subjects will be admitted for treatment on day -1 and receive the first dose of study drug or placebo on day 1 and then treat for 28 days. Subjects from different dose groups were enrolled in turn, the next dose group is conducted on the premise that the D15 safety evaluation was completed after the administration of the previous dose group with the result was tolerance.

Blood samples will be collected on day 1 for 48 hours and day 28 for 72 hours after administration for pharmacokinetic data analysis. Blood lipid will be collected for effectiveness evaluation. PCSK9 and ANGPTL3, Urine and feces were collected for explore analysis.

Conditions: Hypercholesterolemia
Being tested: DC371739 Tablets, Placebo
Keywords: Hypercholesterolemia, Pharmacokinetics, Pharmacodynamics
Medical subject headings: Hypercholesterolemia

What participants receive

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

DC371739 TabletsDrug
Participants received one of 5 dose levels of DC371739 administered as single oral doses.
PlaceboDrug
Placebo orally administered as comparison

Study groups in NCT04927221
Study group	Role	What they receive
DC371739 20mg Dose MAD	Experimental	Orally administered DC371739 tablets QD afer meal Receives: Drug: DC371739 Tablets
DC371739 Placebo MAD	Placebo comparator	Placebo orally administered Receives: Drug: Placebo

What is being measured

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

tolerability evaluation
12-lead ECG
Measured: From informed consent until Day 42.
Safety evaluation
adverse events (AE/SAEs)
Measured: From informed consent until Day 42.
Pharmacodynamic evaluation
Cmax
Measured: From informed consent until Day 31.

Secondary outcomes (1)

Effective evaluation
LDL-C
Measured: From informed consent until Day 29.

Timeline

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

1 Apr 202121 Dec 2021

First posted15 Jun 2021
Study start1 Apr 2021
Primary completion21 Dec 2021
Study completion21 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies 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: Participants are assigned to one of 5 groups in parallel for the duration of the study
Masking: Single blind
Who is masked: Participant
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04927221
Sponsor's protocol ID: JYD0102
Status last verified: May 2021
First submitted: 29 May 2021
Last updated: 16 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang J, Zhao J, Yan C, Xi C, Wu C, Zhao J, Li F, Ding Y, Zhang R, Qi S, Li X, Liu C, Hou W, Chen H, Wang Y, Wu D, Chen K, Jiang H, Huang H, Liu H. Identification and evaluation of a lipid-lowering small compound in preclinical models and in a Phase I trial. Cell Metab. 2022 May 3;34(5):667-680.e6. doi: 10.1016/j.cmet.2022.03.006. Epub 2022 Apr 14.
PubMed 35427476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
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Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease: A Randomized Controlled Trial
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DC739 Multiple-Dose in Hypercholesterolemic Subjects.
ClinicalTrials.gov ID: NCT04927221
Acronym / sponsor ID: JYD0102
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia, Pharmacokinetics, Pharmacodynamics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
Collaborators: The First Hospital of Jilin University
Study start: 1 Apr 2021 (actual)
Primary completion: 21 Dec 2021 (actual)
Study completion: 21 Dec 2021 (actual)
First posted: 15 Jun 2021 (actual)
Results: Not posted in the source record

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: Single blind (participant)
Number of arms: 2
Model description: Participants are assigned to one of 5 groups in parallel for the duration of the study

Arm	Type	Receives
DC371739 20mg Dose MAD	Experimental	Drug: DC371739 TabletsOrally administered DC371739 tablets QD afer meal
DC371739 Placebo MAD	Placebo comparator	Drug: PlaceboPlacebo orally administered

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men and women aged 18 to 65 years (inclusive 18 and 65);
Body mass index of 18 to 32 kg/m2(inclusive);
Hypercholesterolemia subjects with LDL-C≥2.6mmol/L(100mg/dL);
Male or female subjects who had no immediate plans to have children, the serum pregnancy test of women was negative at the time of screening, and agreed to use strict contraceptive measures throughout the study period and up to 6 months after the last dose;

Key exclusion criteria (6 listed)

ECG confirmed that the QT interval was prolonged > 450ms (QT interval corrected for heart rate by Bazetts formula [QTCB]);
Use of statins (lovastatin, simvastatin, pravastatin, mevastatin, fluvastatin, atorvastatin, cerivastatin, rosuvastatin, pitavastatin, etc.) , ezetimibe, Xuezhikan, and other lipid-lowering treatment within 2 months prior to screening; use of PCSK9 monoclonal antibodies , fibric acid drugs (such as fenofibrate, gemfibrozil) and probucol within 3 months prior to screening;
Use of warfarin, systemic steroids, cyclosporine, or other immunosuppressive therapy within months prior to screening;
Subjects with HIV-AB , HBsAg, ANTI-TP , HCV-AB positive;
A history of prescription drug abuse and illicit drug abuse within 6 months prior to screening;

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
DC371739 TabletsParticipants received one of 5 dose levels of DC371739 administered as single oral doses.	Drug	DC371739 20mg Dose MAD
PlaceboPlacebo orally administered as comparison	Drug	DC371739 Placebo MAD

Primary outcome

tolerability evaluation
Time frame: From informed consent until Day 42.
12-lead ECG
Safety evaluation
Time frame: From informed consent until Day 42.
adverse events (AE/SAEs)
Pharmacodynamic evaluation
Time frame: From informed consent until Day 31.
Cmax

1 secondary outcome

Effective evaluation
Time frame: From informed consent until Day 29.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Derived from this study: PubMed 35427476Wang J, Zhao J, Yan C, Xi C, Wu C, Zhao J, Li F, Ding Y, Zhang R, Qi S, Li X, Liu C, Hou W, Chen H, Wang Y, Wu D, Chen K, Jiang H, Huang H, Liu H. Identification and evaluation of a lipid-lowering small compound in preclinical models and in a Phase I trial. Cell Metab. 2022 May 3;34(5):667-680.e6. doi: 10.1016/j.cmet.2022.03.006. Epub 2022 Apr 14.

Related trials for Hypercholesterolemia

RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Hyperlipidemia, Hypercholesterolemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease: A Randomized Controlled Trial
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia

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.

The record lists no contact. Use the official record to reach the sponsor.

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 DC371739 Tablets in people with Hypercholesterolemia, run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.

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 6 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 16 Mar 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

tolerability evaluation (time frame: From informed consent until Day 42.). The study lists 3 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 NCT04927221, which also lists 1 linked publication.

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 16 Mar 2022.