HypercholesterolemiaPhase 2NCT04173403
A Long-term Study of AK102 in Patients With Hypercholesterolemia
A Phase 2 study testing 450mg AK102, 300mg AK102 and 150mg AK102 in people with Hypercholesterolemia, run by Akeso at 1 site in China.
Trial summary
This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- 450mg AK102, 300mg AK102 and 150mg AK102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2019to 17 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Body weight ≥ 40 kg for both men and women.
- Participated in the AK102-202 study, and completed the AK102-202 study last visit.
Who cannot join
- Poor compliance in AK102-202 study per investigator's judgement.
- AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
- Prior use of PCSK9 inhibitors other than AK102.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
About this study
Official title: A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia
This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.
- Conditions
- Hypercholesterolemia
- Being tested
- 450mg AK102, 300mg AK102, 150mg AK102, Statins and/or Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
450mg AK102Drug
AK102 Q4W
300mg AK102Drug
AK102 Q4W
150mg AK102Drug
AK102 Q2W
Statins and/or EzetimibeDrug
Lipid-lowering therapies
| Study group | Role | What they receive |
|---|---|---|
| AK102 | Experimental | 450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection; Receives: Drug: 450mg AK102; Drug: 300mg AK102; Drug: 150mg AK102; Drug: Statins and/or Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
Measured: Week 52
Secondary outcomes (10)
Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0
Measured: From baseline through 52 weeks
Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol
Measured: From baseline through 52 weeks
Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol
Measured: From baseline through 52 weeks
Percent Change From Baseline in Serum Triglyceride (TG) cholesterol
Measured: From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein B (Apo B)
Measured: From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)
Measured: From baseline through 52 weeks
Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)
Measured: From baseline through 52 weeks
Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Measured: From baseline through 52 weeks
Concentrations of AK102 in Serum
Measured: From baseline through 52 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.
Measured: From baseline through 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start4 Nov 2019
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AD Pharma (Guangdong)
- Responsible party
- Sponsor
- Investigators
- Shuyang Zhang, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173403
- Sponsor's protocol ID
- AK102-204
- Status last verified
- Mar 2023
- First submitted
- 17 Nov 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Study to Evaluate the Efficacy and Safety of AK102 in Combination With Lipid-lowering Therapy in Patients With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04173403
- Acronym / sponsor ID
- AK102-204
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- AD Pharma (Guangdong)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 22 Nov 2019 (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.
This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with hypercholesterolemia. Subjects who have participated in the AK102 studies and have completed the last visit,and who, in the opinion of the investigator, are likely to benefit from continued treatment will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK102 | Experimental | Drug: 450mg AK102, Drug: 300mg AK102, Drug: 150mg AK102, Drug: Statins and/or Ezetimibe450mg AK102, Q4W, subcutaneous injection; OR 300mg AK102, Q4W, subcutaneous injection;OR 150mg AK102, Q4W, subcutaneous injection; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent.
- Body weight ≥ 40 kg for both men and women.
- Participated in the AK102-202 study, and completed the AK102-202 study last visit.
Key exclusion criteria (3 listed)
- Poor compliance in AK102-202 study per investigator's judgement.
- AE that led to permanent discontinuation of AK102 occurred during the AK102-202 study period.
- Prior use of PCSK9 inhibitors other than AK102.
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 |
|---|---|---|
| 450mg AK102AK102 Q4W | Drug | AK102 |
| 300mg AK102AK102 Q4W | Drug | AK102 |
| 150mg AK102AK102 Q2W | Drug | AK102 |
| Statins and/or EzetimibeLipid-lowering therapies | Drug | AK102 |
Primary outcome
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52
Time frame: Week 52
10 secondary outcomes
Incidence of treatment-emergent adverse events as assessed by CTCAE V5.0
Time frame: From baseline through 52 weeks
Percent Change From Baseline in High-density lipoprotein (HDL) cholesterol
Time frame: From baseline through 52 weeks
Percent Change From Baseline in non High-density lipoprotein (non-HDL) cholesterol
Time frame: From baseline through 52 weeks
Percent Change From Baseline in Serum Triglyceride (TG) cholesterol
Time frame: From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein B (Apo B)
Time frame: From baseline through 52 weeks
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I)
Time frame: From baseline through 52 weeks
Percent Change From BaPercent Change From Baseline in Total Cholesterol(TC)
Time frame: From baseline through 52 weeks
Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Time frame: From baseline through 52 weeks
Concentrations of AK102 in Serum
Time frame: From baseline through 52 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From baseline through 52 weeks
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 2 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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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.
Shuyang Zhang principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 450mg AK102, 300mg AK102 and 150mg AK102 in people with Hypercholesterolemia, run by Akeso 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 3 inclusion and 3 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 Mar 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. 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?
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.