HypertriglyceridemiaPhase 3NCT02463071

AZD0585 Phase III Long-term Study in Japan

A Phase 3 study testing AZD0585 in people with Hypertriglyceridemia, run by AstraZeneca at 26 sites in Japan.

Completed

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

Trial summary

This study is a randomised, double-blind phase III long-term study to evaluate efficacy and safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients with hyperlipidemia accompanied by hypertriglyceridemia . Read more about this study

Who is it for?: Ages 20 to 130 years
Conditions the study is for: Hypertriglyceridemia
What is being tested?: AZD0585
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 383 participants
Where: 26 sitesJapan
Study dates: 10 Jun 2015to 11 Mar 2017
Phase: Phase 3
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 20 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese men or women, ≥20 years of age.
Subjects must meet all of the following criteria;
Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL
%TG change between Visit 2 and Visit 3 must be within 30%
%LDL-C change between Visit 2 and Visit 3 must be within 25%

Who cannot join

Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.
Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
Current or history of pancreatitis.
Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Japan26 sites

Research Site
Aki-gun, 735-0021
Research Site
Chiba, 261-0004
Research Site
Chofu-shi, 182-0006
Research Site
Fukuoka, 812-0027
Research Site
Fukuoka, 819-8551
Research Site
Fukuyama-shi, 721-0927
Research Site
Funabashi-shi, 273-0046
Research Site
Gifu, 500-8717
Research Site
Itami-shi, 664-0846
Research Site
Kanazawa, 921-8035
Research Site
Kawasaki-shi, 216-0006
Research Site
Koga-shi, 306-0232
Research Site
Komatsu-shi, 923-0861
Research Site
Nagoya, 457-0046
Research Site
Naha, 900-0032
Research Site
Niigata, 950-1104
Research Site
Ōta-ku, 144-0034
Research Site
Sendai, 981-0923
Research Site
Sendai, 983-0039
Research Site
Sendai, 983-0835
Research Site
Shinagawa-ku, 141-6003
Research Site
Shinjuku-ku, 160-0017
Research Site
Takamatsu, 760-0018
Research Site
Takamatsu, 760-0076
Research Site
Toyonaka-shi, 560-0082
Research Site
Urasoe-shi, 901-2132

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase III Long-term Study to Evaluate Efficacy and Safety of 12 Weeks and 52 Weeks of AZD0585 Administration, Respectively, in Japanese Patients With Hyperlipidemia Accompanied by Hypertriglyceridemia.

Conditions: Hypertriglyceridemia
Being tested: AZD0585, AZD0585 placebo
Medical subject headings: Hypertriglyceridemia

What participants receive

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

AZD0585Drug
Also called Epanova
1g soft capsule
AZD0585 placeboDrug
Also called Corn oil
1g soft capsule

Study groups in NCT02463071
Study group	Role	What they receive
AZD0585 2g group	Experimental	AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily Receives: Drug: AZD0585; Drug: AZD0585 placebo
AZD0585 4g group	Experimental	AZD0585 1g × 4 capsules once daily Receives: Drug: AZD0585
Placebo control group	Placebo comparator	AZD0585 placebo 1g × 4 capsules once daily Receives: Drug: AZD0585 placebo

What is being measured

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

Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
Measured: From baseline to Week12
Safety of AZD0585 by Assessment of Adverse Events in Patients
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
Measured: From baseline to Week52

Secondary outcomes (5)

Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol.
Measured: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate.
Measured: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E.
Measured: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Measured: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP
To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).
Measured: From baseline to Week12

Timeline

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

10 Jun 201511 Mar 2017

First posted4 Jun 2015 (estimated)
Study start10 Jun 2015
Primary completion11 Mar 2017
Study completion11 Mar 2017

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 HypertriglyceridemiaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02463071
Sponsor's protocol ID: D5884C00002
Status last verified: Feb 2018
First submitted: 3 Jun 2015
Last updated: 1 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
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A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)

All Hypertriglyceridemia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Phase III Long-term Study to Evaluate Efficacy and Safety of 12 Weeks and 52 Weeks of AZD0585 Administration, Respectively, in Japanese Patients With Hyperlipidemia Accompanied by Hypertriglyceridemia.
ClinicalTrials.gov ID: NCT02463071
Acronym / sponsor ID: D5884C00002
Conditions: Hypertriglyceridemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Jun 2015 (actual)
Primary completion: 11 Mar 2017 (actual)
Study completion: 11 Mar 2017 (actual)
First posted: 4 Jun 2015 (estimated)
Results: Posted 1 Oct 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
AZD0585 2g group	Experimental	Drug: AZD0585, Drug: AZD0585 placeboAZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily
AZD0585 4g group	Experimental	Drug: AZD0585AZD0585 1g × 4 capsules once daily
Placebo control group	Placebo comparator	Drug: AZD0585 placeboAZD0585 placebo 1g × 4 capsules once daily

Who may qualify

Ages: 20 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Japanese men or women, ≥20 years of age.
Subjects must meet all of the following criteria;

Key exclusion criteria (4 listed)

Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.
Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency or familial dysbetalipoproteinemia.
Current or history of pancreatitis.
Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.

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
AZD0585Also: Epanova1g soft capsule	Drug	AZD0585 2g group, AZD0585 4g group
AZD0585 placeboAlso: Corn oil1g soft capsule	Drug	AZD0585 2g group, Placebo control group

Primary outcome

Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides
Time frame: From baseline to Week12
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
Safety of AZD0585 by Assessment of Adverse Events in Patients
Time frame: From baseline to Week52
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.

5 secondary outcomes

Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile
Time frame: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.
Time frame: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile
Time frame: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio
Time frame: From baseline to Week12
Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP
Time frame: From baseline to Week12

Results and safety

Results posted to the registry on 1 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD0585 2g Group	152	140
AZD0585 4g Group	154	138
Placebo Control Group	77	71

Primary outcome: Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides

Time frame: From baseline to Week12. Least squares mean (Standard Error). Unit: % (percent change from baseline)

Measure	AZD0585 2g Group n = 152	AZD0585 4g Group n = 154	Placebo Control Group n = 76
Value	-15.57 (1.70)	-21.78 (1.95)	11.15 (4.65)

AZD0585 2g Group vs Placebo Control Group: Mean Difference (Final Values): -26.72 (95% CI -36.55 to -16.88), p <0.0001, ANCOVA
AZD0585 4g Group vs Placebo Control Group: Mean Difference (Final Values): -32.92 (95% CI -42.93 to -22.92), p <0.0001, ANCOVA

Population analysed: The Full Analysis Set included all randomized patients who had both any baseline and any post-baseline efficacy measurements.

Primary outcome: Safety of AZD0585 by Assessment of Adverse Events in Patients

Time frame: From baseline to Week52. Number. Unit: Participants

Measure	AZD0585 2g Group n = 152	AZD0585 4g Group n = 154	Placebo Control Group n = 77
Any AE	127	135	55
Any AE with outcome = death	1	0	0
Any serious AE	6	6	4
Any AE leading to discontinuation of IP	6	5	1
Any causally related AE	16	36	8
Any severe AE	4	1	0

Population analysed: The Safety Analysis Set included all patients who took at least 1 dose of double-blind investigational product.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs, brief physical findings/clinical assessments, laboratory measurements, vital signs ,and ECGs were assessed throughout the 52-treatment period.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD0585 2g Group	6 of 152 (3.9%)	127 of 152 (83.6%)	1 of 152
AZD0585 4g Group	6 of 154 (3.9%)	135 of 154 (87.7%)	0 of 154
Placebo Control Group	4 of 77 (5.2%)	55 of 77 (71.4%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertriglyceridemia

Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy
Diabetes, Lipodystrophy
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia
Not yet recruitingPhase 2
A Phase II Study of FXR0906 in Patients With Severe Hypertriglyceridemia or Hypertriglyceridemia With ASCVD.
sHTG, HTG With ASCVD (Diagnosed or at Increased Risk)

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.

Kayoko Ikeda, MD principal investigator

Social medial corporation Koyokai Nakajima Hospital

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0585 in people with Hypertriglyceridemia, run by AstraZeneca at 26 sites in Japan.

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 5 inclusion and 4 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 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 1 Oct 2018). 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?

Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides (time frame: From baseline to Week12). The study lists 2 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 NCT02463071.

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 1 Oct 2018.