NCT04964557 (SOLANO) is a Phase 2 clinical trial of AZD8233 in Hyperlipidaemia, sponsored by AstraZeneca.

Who is sponsoring NCT04964557?

NCT04964557 is sponsored by AstraZeneca.

What drugs are being tested in NCT04964557?

Interventions in NCT04964557: AZD8233, Placebo.

What condition does NCT04964557 study?

NCT04964557 studies Hyperlipidaemia.

Is NCT04964557 still recruiting?

NCT04964557 is currently completed. Last updated 15 December 2023.

Are results published for NCT04964557?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-15 · How we verify

NCT04964557: SOLANO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia

Completed Phase 2 Results posted Last updated 15 December 2023

What this trial tests

Phase 2 trial testing AZD8233 in Hyperlipidaemia in 411 participants. Completed in 15 July 2022.

Timeline

7 July 2021

Primary endpoint
15 July 2022

15 July 2022

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	411
Start date	7 July 2021
Primary completion	15 July 2022
Estimated completion	15 July 2022
Sites	66 locations across Denmark, Netherlands, Slovakia, Hungary, Poland, United States, Spain, Czechia

Drugs / interventions tested

AZD8233 — full drug profile →
Placebo

Conditions studied

Hyperlipidaemia — all drugs for Hyperlipidaemia →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 75, any sex, with Hyperlipidaemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Change From Baseline on Serum LDL-C Primary · From baseline to Day 197

Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.

Group	Value	95% CI
AZD8233	-56.7	-60.8 – -52.7
Placebo	5.6	1.5 – 9.6

Percentage Change From Baseline on Serum PCSK9 Secondary · From baseline to Day 197

Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.

Group	Value	95% CI
AZD8233	-77.5	-81.1 – -74
Placebo	-0.8	-4.3 – 2.6

Plasma Concentration of AZD8233 Secondary · Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197

AZD8233 full length ASO concentrations in plasma were summarised by descriptive statistics by sampling time point and listed on individual level based on the PK analysis set.

Day 29

Group	Value	95% CI
AZD8233	0.2648	± 82.8352

Day 85

Group	Value	95% CI
AZD8233	0.3927	± 84.9378

Day 141

Group	Value	95% CI
AZD8233	0.5749	± 161.9301

Day 183

Group	Value	95% CI
AZD8233	1.0441	± 178.5196

Day 197

Group	Value	95% CI
AZD8233	0.6975	± 208.2431

Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period Secondary · Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281

Number of ADA positive subjects at each time point during the treatment period and follow-up period.

Day 1

Group	Value	95% CI
AZD8233	6
Placebo	4

Day 29

Group	Value	95% CI
AZD8233	15
Placebo	3

Day 57

Group	Value	95% CI
AZD8233	16
Placebo	3

Day 85

Group	Value	95% CI
AZD8233	18
Placebo	3

Day 113

Group	Value	95% CI
AZD8233	21
Placebo	3

Day 141

Group	Value	95% CI
AZD8233	25
Placebo	2

Day 169

Group	Value	95% CI
AZD8233	31
Placebo	2

Day 197

Group	Value	95% CI
AZD8233	37
Placebo	3

Number of Subjects With Adverse Events (AEs) Primary · On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.

Please refer to the adverse event module for specifics.

Group	Value	95% CI
AZD8233	141
Placebo	127

Vital Signs - Temperature Primary · Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Temperature at each scheduled visit by treatment.

Baseline

Group	Value	95% CI
AZD8233	36.434	± 0.437
Placebo	36.369	± 0.389

Day 15

Group	Value	95% CI
AZD8233	36.344	± 0.404
Placebo	36.387	± 0.378

Day 29

Group	Value	95% CI
AZD8233	36.360	± 0.422
Placebo	36.361	± 0.386

Day 57

Group	Value	95% CI
AZD8233	36.340	± 0.420
Placebo	36.396	± 0.368

Day 85

Group	Value	95% CI
AZD8233	36.360	± 0.416
Placebo	36.362	± 0.363

Day 113

Group	Value	95% CI
AZD8233	36.359	± 0.391
Placebo	36.399	± 0.348

Day 141

Group	Value	95% CI
AZD8233	36.335	± 0.398
Placebo	36.373	± 0.341

Day 169

Group	Value	95% CI
AZD8233	36.304	± 0.454
Placebo	36.353	± 0.411

Vital Sign - Weight Primary · Baseline and Day 281.

Mean and standard deviation of Weight at each scheduled visit by treatment.

Baseline

Group	Value	95% CI
AZD8233	86.642	± 17.054
Placebo	88.750	± 17.566

Day 281

Group	Value	95% CI
AZD8233	85.493	± 16.561
Placebo	88.759	± 18.110

Number of Participants With an ECG Determined to be Abnormal and Clinically Significant Primary · Baseline, Days 85, 169, 225, and 281.

Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment

Baseline

Group	Value	95% CI
AZD8233	0
Placebo	0

Day 85

Group	Value	95% CI
AZD8233	1
Placebo	1

Day 169

Group	Value	95% CI
AZD8233	0
Placebo	0

Day 225

Group	Value	95% CI
AZD8233	0
Placebo	0

Day 281

Group	Value	95% CI
AZD8233	0
Placebo	0

Vital Sign - Systolic Blood Pressure Primary · Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.

Baseline

Group	Value	95% CI
AZD8233	130.918	± 13.284
Placebo	131.325	± 11.281

Day 15

Group	Value	95% CI
AZD8233	130.438	± 13.541
Placebo	131.198	± 12.711

Day 29

Group	Value	95% CI
AZD8233	130.741	± 13.363
Placebo	133.152	± 11.881

Day 57

Group	Value	95% CI
AZD8233	130.754	± 12.536
Placebo	131.465	± 14.073

Day 85

Group	Value	95% CI
AZD8233	131.913	± 12.083
Placebo	132.111	± 12.238

Day 113

Group	Value	95% CI
AZD8233	131.974	± 12.622
Placebo	132.493	± 12.022

Day 141

Group	Value	95% CI
AZD8233	131.386	± 14.246
Placebo	132.041	± 14.081

Day 169

Group	Value	95% CI
AZD8233	130.959	± 11.874
Placebo	132.706	± 12.481

Vital Sign - Diastolic Blood Pressure Primary · Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.

Baseline

Group	Value	95% CI
AZD8233	78.937	± 7.608
Placebo	78.562	± 6.134

Day 15

Group	Value	95% CI
AZD8233	78.318	± 8.060
Placebo	78.559	± 6.946

Day 29

Group	Value	95% CI
AZD8233	78.408	± 8.157
Placebo	79.611	± 6.779

Day 57

Group	Value	95% CI
AZD8233	78.714	± 7.799
Placebo	79.369	± 7.120

Day 85

Group	Value	95% CI
AZD8233	78.867	± 8.053
Placebo	79.081	± 7.575

Day 113

Group	Value	95% CI
AZD8233	79.164	± 8.393
Placebo	79.584	± 7.152

Day 141

Group	Value	95% CI
AZD8233	78.698	± 8.505
Placebo	78.836	± 7.758

Day 169

Group	Value	95% CI
AZD8233	78.139	± 8.489
Placebo	78.402	± 7.359

Vital Sign - Pulse Rate Primary · Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.

Mean and standard deviation of Pulse rate at each scheduled visit by treatment.

Baseline

Group	Value	95% CI
AZD8233	68.93	± 11.52
Placebo	67.88	± 10.47

Day 15

Group	Value	95% CI
AZD8233	70.63	± 10.07
Placebo	69.48	± 10.42

Day 29

Group	Value	95% CI
AZD8233	68.52	± 9.91
Placebo	68.90	± 10.05

Day 57

Group	Value	95% CI
AZD8233	69.58	± 10.59
Placebo	69.90	± 11.56

Day 85

Group	Value	95% CI
AZD8233	68.90	± 9.87
Placebo	69.53	± 11.10

Day 113

Group	Value	95% CI
AZD8233	70.77	± 10.58
Placebo	70.03	± 10.48

Day 141

Group	Value	95% CI
AZD8233	70.85	± 11.10
Placebo	70.00	± 10.84

Day 169

Group	Value	95% CI
AZD8233	69.35	± 10.44
Placebo	68.38	± 10.31

Treatment Emergent Platelet Count Abnormalities Primary · Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.

Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.

Platelet count < LLN

Group	Value	95% CI
AZD8233	9
Placebo	11

Platelet count > ULN

Group	Value	95% CI
AZD8233	26
Placebo	20

Platelet count < 50 x 10^9/L

Group	Value	95% CI
AZD8233	0
Placebo	0

Platelet count < 75 x 10^9/L

Group	Value	95% CI
AZD8233	1
Placebo	1

Platelet count < 100 x 10^9/L

Group	Value	95% CI
AZD8233	2
Placebo	2

Platelet count < 150 x 10^9/L

Group	Value	95% CI
AZD8233	19
Placebo	21

>30% decrease from baseline

Group	Value	95% CI
AZD8233	14
Placebo	14

<150 x 10^9/L or >30% decrease from baseline

Group	Value	95% CI
AZD8233	28
Placebo	26

Adverse events — posted to ClinicalTrials.gov

Time frame: On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AZD8233

Serious: 18/207 (9%)

Deaths: 3/207

Placebo

Serious: 12/203 (6%)

Deaths: 0/203

Serious adverse events (35 terms)

Reaction	System	AZD8233	Placebo
Non-cardiac chest pain	General disorders	—	—
Amaurosis fugax	Eye disorders	—	—
Duodenal ulcer	Gastrointestinal disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Sudden death	General disorders	—	—
Covid-19 pneumonia	Infections and infestations	—	—
Clostridium difficile colitis	Infections and infestations	—	—
Diverticulitis	Infections and infestations	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Gangrene	Infections and infestations	—	—
Urosepsis	Infections and infestations	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—
Blood creatinine increased	Investigations	—	—
Coagulation time prolonged	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Transitional cell carcinoma urethra	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Carotid artery stenosis	Nervous system disorders	—	—
Bipolar i disorder	Psychiatric disorders	—	—
Mental disorder	Psychiatric disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	AZD8233	Placebo
Covid-19	Infections and infestations	—	—
Injection site reaction	General disorders	—	—
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	—	—
Hypertension	Vascular disorders	—	—

Most-reported serious reactions: Non-cardiac chest pain, Amaurosis fugax, Duodenal ulcer, Inguinal hernia, Sudden death, Covid-19 pneumonia, Clostridium difficile colitis, Diverticulitis.

Data from ClinicalTrials.gov NCT04964557 adverse events section.

Sponsor's own description

AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study aims to evaluate safety, efficacy and tolerability of AZD8233.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

RNA-based therapies in liver metabolic diseases.
Fontanellas A, Berraondo P, Urigo F, Jericó D, et al · · 2025 · cited 9× · PMID 39988358 · DOI 10.1136/gutjnl-2023-331742
Olezarsen and Beyond: Emerging Targeted Treatments for Familial Chylomicronemia Syndrome and Related Triglyceride Disorders.
N M, C B K, D R S. · · 2026 · PMID 41660532 · DOI 10.12997/jla.2026.15.1.72

Verify or expand the search:

Other trials of AZD8233

Trials testing the same drug.

NCT05065463 — To Assess the Pharmacokinetics, Safety, and Tolerability of AZD8233 in Participants With Chronic Kidney Disease (CKD), E · Phase 1 · terminated
NCT04641299 — A Study of AZD8233 in Participants With Dyslipidemia · Phase 2 · completed
NCT03593785 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects Wi · Phase 1 · completed

Other recruiting trials for Hyperlipidaemia

Currently open trials in the same condition.

NCT07339852 — Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies · NA · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

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NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04964557 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 15 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04964557.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04964557: SOLANO

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (35 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of AZD8233

Other recruiting trials for Hyperlipidaemia

Other AstraZeneca trials

Verify against primary sources