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HypercholesterolemiaPhase 2NCT03815812

Multiple Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Chinese Patients With Hypercholesterolemia

A Phase 2 study testing IBI306 in people with Hypercholesterolemia, run by Innovent Biologics (Suzhou) 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

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
IBI306
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
7 Mar 2019to 25 Dec 2019
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria in order to be included in the study:
  • Provide a signed and dated informed consent form;
  • Men or women with an age of 18 to 70 years of age at screening (Inclusive);
  • BMI between18kg/m2 and 30kg/m2(Inclusive);
  • Diagnosis of hyperlipidemia, and taking statins with moderate doses or above for at least 4 weeks;
  • Fasting LDL-C between 100 mg / dl (2.6 mmol / L) and 220 mg / dl (5.7 mmol / L) at screening (Inclusive);
  • Fasting triglycerides ≤ 400 mg (4.5 mmol / L) at screening.

Who cannot join

  • Subjects who do not meet any of the following exclusion criteria cannot be included in the study:
  • Subject's current statin treatment are stable less than 4 weeks prior to random enrollment
  • New York Heart Association (NYHA) III or IV heart failure, or last left ventricular ejection fraction <30%
  • Uncontrolled hypertension, defined as repeated measurements confirmed, sitting systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
  • Diabetic patients have one of the following conditions;
  • Known microvascular and macrovascular complications
Show all 19Show fewer
  • HbA1c>7.5% within 4 weeks before screening
  • Moderate or severe renal insufficiency, defined as the estimated glomerular filtration rate <60 ml / min / 1.73 m2 during screening (calculated using the MDRD formula)
  • Active liver disease or impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the normal upper limit (ULN) at screening.
  • Have previously undergone liver transplant surgery.
  • Creatine kinase (CK) ≥ 3 times the upper limit of normal (ULN) at screening.
  • At the discretion of the investigator, there are known active infections or major blood, kidney, metabolism, gastrointestinal or endocrine dysfunction.
  • Female subject of childbearing potential not willing to use an acceptable method(s) of effective birth control during treatment with investigational product and for an additional 15 weeks after the end of treatment with investigational product. Male subjects are reluctant to inform their female sexual partners about their participation in the clinical study.
  • Female subject is pregnant or breast feeding, planning to become pregnant or planning to breastfeed during treatment with investigational product and/or within 15 weeks after the end of treatment with investigational product..
  • Subjects have been treated with PCSK9 inhibitors or have participated in other PCSK-9 inhibitor studies
  • Subject has known sensitivity to the study drug and its excipients
  • Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment (for example, alcohol or other substance abuse, unable or unwilling to comply with the agreement or mental illness).
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days before randomization since ending treatment on another investigational device or drug study(s) while participating in this study
  • In the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Repeated-dosing, Multiple Ascending Dose Trial to Evaluate the Safety and Tolerability of a Novel PCSK-9 Anti-body, IBI306, in Chinese Patients With Hypercholesterolemia

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol（LDL-C）uptake. In phase I study IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the safety and tolerability of a novel PCSK-9 anti-body, IBI306, in Chinese patients with hypercholesterolemia.

Read the detailed description

A total of 60 patients who meet the criteria for admission and have a clinical diagnosis of hypercholesterolemia and have received statin for at least 4 weeks will be randomized and receive different dose groups of IBI306 or matching placebo. Ascending dose design includes 6 dose levels: 75 mg Q2W, 140 mgQ2W, 300 mg Q4W，420mg Q4W, 450 mg Q6W，and 600 mg Q6W. Total duration of the study per subject is 12 weeks.

Being tested
IBI306, placebo
Medical subject headings
Hypercholesterolemia

What participants receive

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

  • IBI306Drug

    Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W

  • placeboDrug

    Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W

Study groups in NCT03815812
Study groupRoleWhat they receive
IBI306ExperimentalParticipants received one of 6 dose levels of IBI306 administered as multiple subcutaneous dose
Receives: Drug: IBI306
placeboPlacebo comparatorParticipants received matching placebo dose regimen by subcutaneous injection.
Receives: Drug: placebo

What is being measured

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

  1. AEs/SAEs

    • Percentage of participants with adverse events and severity of adverse events from the first dose to the last visit

    Measured: up to 12 weeks

Secondary outcomes (20)

  1. Tmax

    Measured: up to 12 weeks

  2. Cmax

    Measured: up to 12 weeks

  3. area under curve (AUC)

    Measured: up to 12 weeks

  4. volume of distribution (Vd)

    Measured: up to 12 weeks

  5. half-life (T1/2)

    Measured: up to 12 weeks

  6. clearance (CL)

    Measured: up to 12 weeks

  7. accumulation factor (AR)

    Measured: up to 12 weeks

  8. changes in blood PCSK-9 concentrations at different time points before and after administration relative to baseline

    Measured: up to 12 weeks

  9. ADA

    The occurrence of anti-IBI306 antibody (ADA) in serum before and after administration

    Measured: up to 12 weeks

  10. NAb

    The occurrence of neutralizing antibody (NAb) in serum before and after administration

    Measured: up to 12 weeks

  11. Percent change in LDL-C from baseline at 12 weeks

    Measured: baseline and week 12

  12. Changes in LDL-C levels from baseline at 12 weeks

    Measured: baseline and week 12

  13. Percent change in non-HDL-C cholesterol levels from baseline at 12 weeks

    Measured: baseline and week 12

  14. Percent change in ApoB from baseline at 12 weeks

    Measured: baseline and week 12

  15. Percent change in ApoB/ApoA1 ratio from baseline at 12 weeks

    Measured: baseline and week 12

  16. Percent of patients with a 15% or more decrease in LDL-C levels from baseline at 12 weeks

    Measured: baseline and week 12

  17. Percent change in Lp(a) from baseline at 12 weeks

    Measured: baseline and week 12

  18. Percent change in mean LDL-C levels at week 6 and 12 relative to baseline

    Measured: baseline, week 6 and 12

  19. Percent change in mean ApoB levels at week 6 and 12 relative to baseline

    Measured: baseline, week 6 and 12

  20. Percent change in mean Lp(a) levels at week 6 and 12 relative to baseline

    Measured: baseline, week 6 and 12

Timeline

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

  1. First posted24 Jan 2019
  2. Study start7 Mar 2019
  3. Primary completion25 Dec 2019
  4. Study completion25 Dec 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03815812
Sponsor's protocol ID
CIBI306B101
Status last verified
Nov 2023
First submitted
22 Jan 2019
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cui Y, Zhao X, Qi L, Li X, Huang Z, Yang G, Qian L, Deng H, Li H, Huo Y. A Potential Long-Acting LDL-Cholesterol-Lowering PCSK9 Monoclonal Antibody: Randomized, Placebo-Controlled Phase 1 Studies. JACC Asia. 2021 Nov 9;1(3):411-415. doi: 10.1016/j.jacasi.2021.09.002. eCollection 2021 Dec.

    PubMed 36341216

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBI306 in people with Hypercholesterolemia, run by Innovent Biologics (Suzhou) 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 7 inclusion and 19 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 18 Nov 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

AEs/SAEs (time frame: up to 12 weeks). 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 NCT03815812, 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 18 Nov 2023.

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