A Study to Evaluate the Efficacy and Safety of AK102 in Patients With Hyperlipidemia

NCT05255094 | Completed Phase 3 DMC

• 1 other identifier: AK102-301
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled phase 3 clinical study evaluating the efficacy and safety of AK102 in patients with primary hypercholesterolemia and mixed hyperlipidemia.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline of serum LDL-C level

  Percentage change from baseline of serum LDL-C level

  At week 12

Secondary Outcomes (4)

• Percentage change from baseline of serum TC, HDL-C, TG, ApoB, ApoA-I, non HDL-C and Lp(a) levels

  Week 0-12

• The incidence and severity of adverse events (AE)

  Week 0-12

• To evaluate the population pharmacokinetic (PK) characteristics of AK102，such as AK102 concentration

  Week 0-12

• Number and percentage of subjects with positive anti-ak102 antibody (ADA) / neutralizing antibody (NAB) and the time of ADA / nab positivity

  Week 0-12

Study Arms (4)

AK102 regimen 1

EXPERIMENTAL

Biological: AK102

AK102 regimen 2

EXPERIMENTAL

Biological: AK102

Placebo 1

PLACEBO COMPARATOR

Drug: Placebo

Placebo 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AK102 BIOLOGICAL

Administered AK102 by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

AK102 regimen 1

Placebo DRUG

Administered placebo by subcutaneous injection every 2 weeks Drug: Statins and/or Ezetimibe lipid-lowering therapies

Placebo 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• Pregnant or lactating women.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 24, 2022
• Study Start: November 3, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)