HyperlipidaemiaPhase 2SOLANONCT04964557

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

A Phase 2 study testing AZD8233 in people with Hyperlipidaemia, run by AstraZeneca at 66 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hyperlipidaemia
What is being tested?: AZD8233
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 411 participants
Where: 66 sitesin 8 countries
Study dates: 7 Jul 2021to 15 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 screening
Participants are receiving a stable dose (≥ 3 months) of maximally tolerated statin and/or ezetimibe therapy
Male or female of non-childbearing potential
Signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses

Who cannot join

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
Poorly controlled T2DM, defined as HbA1c > 10%
Acute ischaemic cardiovascular events including stroke within 30 days, or heart failure with New York Heart Association (NYHA) Class III to IV
Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds)

Show all 32Show fewer

High-risk of bleeding diathesis or anti-platelet therapy other than low dose aspirin (≤100mg/day).
Malignancy within the last 10 years
Recipient of any major organ transplant
LDL or plasma apheresis within 12 months prior to randomisation
Uncontrolled hypertension defined as average supine SBP > 160 mmHg or DBP > 90 mmHg
Heart rate after 10 minutes supine rest < 50 or > 100 bpm
Any laboratory values with the following deviations at the Screening Visit; test may be repeated at the discretion of the investigator if abnormal:
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV)
ALT > 1.5 × ULN
AST > 1.5 × ULN
TBL > ULN
ALP > 1.5 × ULN
WBC < lower limit of normal (LLN).
Haemoglobin < 12 g/dL in males or < 11 g/dL in females
Platelet count ≤ LLN
aPTT > ULN or Prothrombin Time > ULN
UACR > 11 mg/mmol (100 mg/g)
UPCR > 300 mg/g
Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG
QTcF > 470 ms; high degree atrioventricular (AV)-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias
History of drug and/or alcohol abuse or a positive screen for drugs of abuse
Use of warfarin, direct or indirect thrombin inhibitors or factor Xa inhibitors
Mipomersen, or lomitapide within 12 months prior to randomisation
Any fibrate therapy other than fenofibrate; if the participant is on fenofibrate therapy, the dose should be stable for at least 6 weeks prior to randomisation
Previous administration of AZD8233/AZD6615) or inclisiran (LEQVIO ® Novartis)
Use of evolocumab (REPATHA® Amgen) and alirocumab (PRALUENT® Regeneron) within 3 months of screening

Trial locations and contacts

66 sites in 8 countries.

Country

City, postcode or hospital

66 sites in 8 countries

United States16 sites

Research Site
Canoga Park, California, 91303
Research Site
Cincinnati, Ohio, 45219
Research Site
Cincinnati, Ohio, 45246
Research Site
Fargo, North Dakota, 58104
Research Site
Greensboro, North Carolina, 27408
Research Site
Huntsville, Alabama, 35801
Research Site
Indianapolis, Indiana, 46260
Research Site
Inverness, Florida, 34452
Research Site
Jacksonville, Florida, 32216
Research Site
Lincoln, California, 95648
Research Site
Meridian, Idaho, 83646
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
New Windsor, New York, 12553
Research Site
Pembroke Pines, Florida, 33024
Research Site
Stow, Ohio, 44224
Research Site
Suffolk, Virginia, 23435

Other trials in United States

Czechia10 sites

Research Site
Benešov, 256 01
Research Site
Brandýs nad Labem, 250 01
Research Site
Brno, 603 00
Research Site
Jaroměř, 551 01
Research Site
Liberec, 460 01
Research Site
Louny, 440 01
Research Site
Ostrava-Dubina, 700 30
Research Site
Příbram, 261 01
Research Site
Teplice, 415 01
Research Site
Uherské Hradiště, 686 01

Other trials in Czechia

Denmark8 sites

Research Site
Aarhus N, 8200
Research Site
Herlev, 2730
Research Site
Herning, 7400
Research Site
Hvidovre, 2650
Research Site
København NV, 2400
Research Site
Roskilde, 4000
Research Site
Svendborg, 5700
Research Site
Viborg, 8800

Other trials in Denmark

Poland8 sites

Research Site
Bydgoszcz, 85-079
Research Site
Chrzanów, 32-500
Research Site
Krakow, 30-082
Research Site
Lodz, 91-002
Research Site
Puławy, 24-100
Research Site
Ruda Śląska, 41-710
Research Site
Tychy, 43-100
Research Site
Wierzchosławice, 33-122

Other trials in Poland

Slovakia7 sites

Research Site
Bratislava, 831 03
Research Site
Brezno, 977 01
Research Site
Lučenec, 984 01
Research Site
Prešov, 080 01
Research Site
Rožňava, 048 01
Research Site
Svidník, 08901
Research Site
Trebišov, 7501

Other trials in Slovakia

Spain7 sites

Research Site
A Coruña, 15006
Research Site
Ferrol, 15405
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41009
Research Site
Seville, 41014
Research Site
Zaragoza, 50009

Other trials in Spain

Netherlands6 sites

Research Site
Amsterdam, 1105 AZ
Research Site
Doetinchem, 7009 BL
Research Site
Ede, 6716 RP
Research Site
Gouda, 2803 HH
Research Site
Harderwijk, 3844 DG
Research Site
Rotterdam, 3045 PM

Other trials in Netherlands

Hungary4 sites

Research Site
Balatonfüred, 8230
Research Site
Békéscsaba, 5600
Research Site
Debrecen, 4032
Research Site
Orosháza, 5900

Other trials in Hungary

About this study

Official title: A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants With Hyperlipidaemia

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.

Read the detailed description

This is a randomized parallel, double-blind, placebo-controlled Phase 2b study in approximately 376 participants with hyperlipidaemia. The primary objective of the study is to assess the safety and tolerability of AZD8233 as compared with placebo, and the effect of AZD8233 versus placebo on relative change in LDL-C. The study will be conducted at up to 100 sites in up to 8 countries.

The screening period starts up to 28 days before the randomization visit and ends on Day -1. Eligible participants will attend 1 enrollment visit and 15 visits during the treatment period and 2 additional visits during the safety follow up period.

Conditions: Hyperlipidaemia
Being tested: AZD8233, Placebo
Keywords: AZD8233, Efficacy, PK, PD, Safety, Tolerability
Medical subject headings: Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD8233Drug
PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
PlaceboDrug
Placebo solution

Study groups in NCT04964557
Study group	Role	What they receive
AZD8233	Experimental	AZD8233 for subcutaneous use Receives: Drug: AZD8233
Placebo	Placebo comparator	Placebo solution for subcutaneous injection Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change From Baseline on Serum LDL-C
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
Measured: From baseline to Day 197
Number of Subjects With Adverse Events (AEs)
Please refer to the adverse event module for specifics.
Measured: 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.
Vital Signs - Temperature
Mean and standard deviation of Temperature at each scheduled visit by treatment.
Measured: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Vital Sign - Weight
Mean and standard deviation of Weight at each scheduled visit by treatment.
Measured: Baseline and Day 281.
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment
Measured: Baseline, Days 85, 169, 225, and 281.
Vital Sign - Systolic Blood Pressure
Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.
Measured: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Vital Sign - Diastolic Blood Pressure
Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.
Measured: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Vital Sign - Pulse Rate
Mean and standard deviation of Pulse rate at each scheduled visit by treatment.
Measured: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.
Treatment Emergent Platelet Count Abnormalities
Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.
Measured: Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.

Secondary outcomes (3)

Percentage Change From Baseline on Serum PCSK9
Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.
Measured: From baseline to Day 197
Plasma Concentration of AZD8233
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.
Measured: Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Number of ADA positive subjects at each time point during the treatment period and follow-up period.
Measured: Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 202115 Jul 2022

First posted16 Jul 2021
Study start7 Jul 2021
Primary completion15 Jul 2022
Study completion15 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyperlipidaemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 411 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04964557
Sponsor's protocol ID: D7990C00004
Other IDs: 2020-005845-18
Acronym: SOLANO
Status last verified: Nov 2023
First submitted: 15 Jun 2021
Last updated: 15 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperlipidaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants With Hyperlipidaemia
ClinicalTrials.gov ID: NCT04964557
Acronym / sponsor ID: SOLANO / D7990C00004
Conditions: Hyperlipidaemia
Keywords: AZD8233, Efficacy, PK, PD, Safety, Tolerability
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 411 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Jul 2021 (actual)
Primary completion: 15 Jul 2022 (actual)
Study completion: 15 Jul 2022 (actual)
First posted: 16 Jul 2021 (actual)
Results: Posted 15 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AZD8233	Experimental	Drug: AZD8233AZD8233 for subcutaneous use
Placebo	Placebo comparator	Drug: PlaceboPlacebo solution for subcutaneous injection

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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 screening
Participants are receiving a stable dose (≥ 3 months) of maximally tolerated statin and/or ezetimibe therapy
Male or female of non-childbearing potential

Key exclusion criteria (32 listed)

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
Poorly controlled T2DM, defined as HbA1c > 10%
Acute ischaemic cardiovascular events including stroke within 30 days, or heart failure with New York Heart Association (NYHA) Class III to IV

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
AZD8233PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.	Drug	AZD8233
PlaceboPlacebo solution	Drug	Placebo

Primary outcome

Percentage Change From Baseline on Serum LDL-C
Time frame: From baseline to Day 197
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
Number of Subjects With Adverse Events (AEs)
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.
Please refer to the adverse event module for specifics.
Vital Signs - Temperature
Time frame: 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.
Vital Sign - Weight
Time frame: Baseline and Day 281.
Mean and standard deviation of Weight at each scheduled visit by treatment.
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Time frame: 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
Vital Sign - Systolic Blood Pressure
Time frame: 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.
Vital Sign - Diastolic Blood Pressure
Time frame: 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.
Vital Sign - Pulse Rate
Time frame: 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.
Treatment Emergent Platelet Count Abnormalities
Time frame: 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.

3 secondary outcomes

Percentage Change From Baseline on Serum PCSK9
Time frame: From baseline to Day 197
Plasma Concentration of AZD8233
Time frame: Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Time frame: Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281

Results and safety

Results posted to the registry on 15 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD8233	206	196
Placebo	205	201

Primary outcome: Percentage Change From Baseline on Serum LDL-C

Time frame: From baseline to Day 197. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	AZD8233 n = 206	Placebo n = 205
Value	-56.7 (-60.8 to -52.7)	5.6 (1.5 to 9.6)

AZD8233 vs Placebo: Mean Difference (Final Values): -62.3 (95% CI -68 to -56.6), p <0.001, ANCOVA

Population analysed: Full analysis set includes all subjects who were randomly assigned to study intervention. Subjects were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.

Primary outcome: Number of Subjects With Adverse Events (AEs)

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.. Count of participants. Unit: Participants

Measure	AZD8233 n = 207	Placebo n = 203
Value	141	127

Population analysed: The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.

Primary outcome: Vital Signs - Temperature

Time frame: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.. Mean (Standard Deviation). Unit: Celsius

Measure	AZD8233 n = 207	Placebo n = 203
Baseline	36.434 (0.437)	36.369 (0.389)
Day 15	36.344 (0.404)	36.387 (0.378)
Day 29	36.360 (0.422)	36.361 (0.386)
Day 57	36.340 (0.420)	36.396 (0.368)
Day 85	36.360 (0.416)	36.362 (0.363)
Day 113	36.359 (0.391)	36.399 (0.348)
Day 141	36.335 (0.398)	36.373 (0.341)
Day 169	36.304 (0.454)	36.353 (0.411)

Population analysed: Safety analysis set, the number analyzed represents the number of participants with available temperature data at that time point.

Primary outcome: Vital Sign - Weight

Time frame: Baseline and Day 281.. Mean (Standard Deviation). Unit: kg

Measure	AZD8233 n = 207	Placebo n = 203
Baseline	86.642 (17.054)	88.750 (17.566)
Day 281	85.493 (16.561)	88.759 (18.110)

Population analysed: Safety analysis set, the number analyzed represents the number of participants with available weight data at that time point.

3 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD8233	18 of 207 (8.7%)	69 of 207 (33.3%)	3 of 207
Placebo	12 of 203 (5.9%)	62 of 203 (30.5%)	0 of 203

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSRsynopsis\_redactedLink provided by the sponsor.
CSP\_redactedLink provided by the sponsor.
SAP\_redactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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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.

66 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD8233 in people with Hyperlipidaemia, run by AstraZeneca at 66 sites in 8 countries.

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 6 inclusion and 32 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Czechia, Denmark, Poland, Slovakia and 3 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 on Serum LDL-C (time frame: From baseline to Day 197). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04964557.

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 15 Dec 2023.