HyperlipidemiaPhase 3NCT05260411
A Study to Evaluate the Efficacy and Safety of AK102 Q6W in Patients With Hyperlipidemia
A Phase 3 study testing AK102 in people with Hyperlipidemia, run by Akeso at 2 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- AK102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 2 sitesChina
- Study dates
- 26 Jan 2022to 19 Dec 2022
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject understand and voluntarily sign the written Inform Consent Form (ICF).
- Male or female ≥ 18 to ≤ 80 years of age.
- The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
- TG ≤ 4.5 mmol/L (400 mg/dl)
Who cannot join
- Known homozygous familial hypercholesterolemia.
- Received PCSK9 inhibitors within 6 months before randomization.
- Known sensitivity to PCSK9 inhibitors and any substances to be administered.
- Severe renal dysfunction.
- Previously received organ transplantation.
- Uncontrolled hypothyroidism or hyperthyroidism.
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- Uncontrolled hypertension.
- Known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc.
- History of malignancy of any organ system within the past 5 years.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhongshan Hospital, Fudan Hospital
Shanghai
About this study
Official title: A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
This is a randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.
Read the detailed description
This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.
- Conditions
- Hyperlipidemia
- Being tested
- AK102, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK102Biological
Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
AK102Biological
Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
PlaceboDrug
Administered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies
| Study group | Role | What they receive |
|---|---|---|
| AK102 regimen 1 | Experimental | Not described Receives: Biological: AK102 |
| AK102 regimen 2 | Experimental | Not described Receives: Biological: AK102 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline of serum LDL-C level
Measured: At week 12
Secondary outcomes (14)
Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels
Measured: Week 0-24
The incidence and severity of adverse events (AE)
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(t1/2)
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(AUC）
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(Vd)
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(Tmax)
Measured: Week 0-24
Evaluate the changes of free PCSK9 concentration
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(Cmax)
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(CL)
Measured: Week 0-24
Evaluate the changes of AK102 PK parameters(MRT)
Measured: Week 0-24
The number and percentage of anti AK102 antibody (ADA)positive subjects
Measured: Week 0-24
The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects
Measured: Week 0-24
the time of ADA positive
Measured: Week 0-24
the time of nab positive
Measured: Week 0-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start26 Jan 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260411
- Sponsor's protocol ID
- AK102-302
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Study Evaluating the Efficacy and Safety of AK102 Q6W in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT05260411
- Acronym / sponsor ID
- AK102-302
- Conditions
- Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 2 Mar 2022 (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 randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of AK102 Q6W in patients with primary hypercholesterolemia and mixed hyperlipidemia.
Detailed description
This is a Phase 3 clinical study to evaluate the efficacy and safety of AK102 Q6W, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK102 regimen 1 | Experimental | Biological: AK102 |
| AK102 regimen 2 | Experimental | Biological: AK102 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject understand and voluntarily sign the written Inform Consent Form (ICF).
- Male or female ≥ 18 to ≤ 80 years of age.
- The fasting serum LDL-C level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment.
- TG ≤ 4.5 mmol/L (400 mg/dl)
Key exclusion criteria (9 listed)
- Known homozygous familial hypercholesterolemia.
- Received PCSK9 inhibitors within 6 months before randomization.
- Known sensitivity to PCSK9 inhibitors and any substances to be administered.
- Severe renal dysfunction.
- Previously received organ transplantation.
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 |
|---|---|---|
| AK102Administered AK102 450 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies | Biological | AK102 regimen 1 |
| AK102Administered AK102 600 mg by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies | Biological | AK102 regimen 2 |
| PlaceboAdministered placebo by subcutaneous injection every 6 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies | Drug | Placebo |
Primary outcome
Percentage change from baseline of serum LDL-C level
Time frame: At week 12
14 secondary outcomes
Percentage change from baseline of serum LDL-C, TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels
Time frame: Week 0-24
The incidence and severity of adverse events (AE)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(t1/2)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(AUC）
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(Vd)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(Tmax)
Time frame: Week 0-24
Evaluate the changes of free PCSK9 concentration
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(Cmax)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(CL)
Time frame: Week 0-24
Evaluate the changes of AK102 PK parameters(MRT)
Time frame: Week 0-24
The number and percentage of anti AK102 antibody (ADA)positive subjects
Time frame: Week 0-24
The number and percentage of anti AK102 neutralizing antibody (NAB) positive subjects
Time frame: Week 0-24
the time of ADA positive
Time frame: Week 0-24
the time of nab positive
Time frame: Week 0-24
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 6 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK102 in people with Hyperlipidemia, run by Akeso at 2 sites 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 9 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage change from baseline of serum LDL-C level (time frame: At week 12). 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 6 Mar 2025.