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Antisense Oligonucleotide

AZD8233 for High Cholesterol (SOLANO Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 15, day 29, day 43, day 57, day 71, day 85, day 99, day 113, day 127, day 141, day 155, day 169, day 183, day 197, day 225, day 281
Awards & highlights

SOLANO Trial Summary

This study is evaluating whether a new drug can lower cholesterol levels.

Eligible Conditions
  • High Cholesterol

SOLANO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 15, day 29, day 43, day 57, day 71, day 85, day 99, day 113, day 127, day 141, day 155, day 169, day 183, day 197, day 225, day 281
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 15, day 29, day 43, day 57, day 71, day 85, day 99, day 113, day 127, day 141, day 155, day 169, day 183, day 197, day 225, day 281 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Number of Subjects With Adverse Events (AEs)
Percentage Change From Baseline on Serum LDL-C
+6 more
Secondary outcome measures
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Percentage Change From Baseline on Serum PCSK9
Plasma Concentration of AZD8233
Other outcome measures
Number of subjects with adverse events (AEs)
Number of subjects with an ECG determined to be abnormal and clinically significant
Number of subjects with clinically significant hematology and/or clinical chemistry parameters as defined by AEs
+3 more

Side effects data

From 2021 Phase 2 trial • 119 Patients • NCT04641299
10%
Abdominal pain
10%
Hypertension
7%
Abdominal pain upper
7%
Upper respiratory tract infection
7%
Injection site pain
7%
Transaminases increased
3%
Liver function test increased
3%
Skin abrasion
3%
Sinusitis
3%
Vertigo
3%
Diarrhoea
3%
Pyrexia
3%
Covid-19
3%
Leukopenia
3%
Tooth infection
3%
Facial bones fracture
3%
Fall
3%
Joint injury
3%
Radius fracture
3%
Wrist fracture
3%
Hypoglycaemia
3%
Hypokalaemia
3%
Musculoskeletal chest pain
3%
Neck pain
3%
Headache
3%
Radiculopathy
3%
Pollakiuria
3%
Cough
3%
Skin laceration
3%
Concussion
3%
Nausea
3%
Injection site haematoma
3%
Asymptomatic covid-19
3%
Urinary tract infection
3%
Alanine aminotransferase increased
3%
Hepatic enzyme increased
3%
Wrist deformity
3%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD8233 High Dose
AZD8233 Medium Dose
AZD8233 Low Dose
Placebo

SOLANO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD8233Experimental Treatment1 Intervention
AZD8233 for subcutaneous use
Group II: PlaceboPlacebo Group1 Intervention
Placebo solution for subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD8233
2018
Completed Phase 2
~610

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,570 Total Patients Enrolled
9 Trials studying High Cholesterol
11,022 Patients Enrolled for High Cholesterol

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
2021. "A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04964557.
~110 spots leftby Apr 2025
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