NL-OMON52196
Completed
Phase 2
A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants with Hyperlipidaemia (SOLANO) - SOLANO
Astra Zeneca0 sites26 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- High Blood Cholesterol levels
- Sponsor
- Astra Zeneca
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Participant must be 18 to 75 years of age, inclusive, at the time of signing
- •the informed consent
- •\- Participants who have a fasting LDL\-C \>\= 70 mg/dL (1\.8 mmol/L) but \< 190 mg/dL
- •(4\.9 mmol/L) at screening
- •\- Participants who have fasting triglycerides \< 400 mg/dL (\< 4\.52 mmol/L) at
- •\- Participants are receiving a stable dose (\>\= 3 months) of maximally tolerated
- •statin and/or ezetimibe therapy at screening
- •\- Male or female of non\-childbearing potential
- •\- Signed and dated written informed consent prior to any mandatory study
- •specific procedures, sampling, and analyses
Exclusion Criteria
- •\- eGFR \< 40 mL/min/1\.73m2 using the CKD\-EPI
- •\- History or presence of gastrointestinal, hepatic or renal disease or any
- •other conditions known to interfere with absorption, distribution, metabolism
- •or excretion of drugs
- •\- Any uncontrolled or serious disease, or any medical (eg,. known major active
- •infection or major haematological, renal, metabolic, gastrointestinal or
- •endocrine dysfunction) or surgical condition that, in the opinion of the
- •investigator, may either interfere with participation in
- •the clinical study and/or put the participant at significant risk (according to
- •the investigator's judgment) if he/she participates in the clinical study
Outcomes
Primary Outcomes
Not specified
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