HypercholesterolemiaPhase 1NCT01959971
Effect of Alirocumab on Lipid Metabolism in Adults With Elevated LDL-Cholesterol
A Phase 1 study testing alirocumab in people with Hypercholesterolemia, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective: To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- alirocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and < 190 mg/dL at Screening.
Who cannot join
- LDL-C ≥ 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
- Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational Site Number 840001
New York, New York, 10032
About this study
Official title: A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Read more
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
- Various parameters of the metabolism and turnover in plasma of different lipoproteins
- Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))
- Lipoprotein particle size profile
- PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.
Read the detailed description
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- alirocumab, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alirocumabDrug
Also called SAR236553, REGN727, Praluent
Pharmaceutical form:Solution for injection
Route of administration: Subcutaneous
PlaceboDrug
Pharmaceutical form:Solution for injection
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Placebo - Alirocumab | Experimental | Injection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks Receives: Drug: alirocumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment
Measured: baseline and at 12 days after last dose of alirocumab
Secondary outcomes (8)
Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)
Measured: baseline and at 12 days after last dose of alirocumab
Change in post-heparin hepatic lipase and lipoprotein lipase activities
Measured: baseline and at 2 days after last dose of alirocumab
Change in lipids and apolipoproteins in plasma lipids panel
Measured: baseline and at 2 days and at 11 days after last dose of alirocumab
Assessment of Lipoprotein particle size profiles
Measured: baseline and at 2 days and at 11 days after last dose of alirocumab
Assessment of serum concentrations of PCSK9
Measured: baseline and up to 2 weeks after last dose of alirocumab
Assessment of safety parameters (clinical laboratory, ECG, vital signs)
Measured: up to 10 weeks after last dose of alirocumab
Assessment of the serum concentration of alirocumab
Measured: baseline and up to 2 weeks after last dose of alirocumab
Assessment of the serum concentration of anti-alirocumab antibodies
Measured: baseline and up to 10 weeks after last dose of alirocumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 1
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Model description
- Single-sequence crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959971
- Sponsor's protocol ID
- PDY13670
- Other IDs
- U1111-1141-4567
- Status last verified
- Apr 2017
- First submitted
- 7 Oct 2013
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Reyes-Soffer G, Pavlyha M, Ngai C, Thomas T, Holleran S, Ramakrishnan R, Karmally W, Nandakumar R, Fontanez N, Obunike J, Marcovina SM, Lichtenstein AH, Matthan NR, Matta J, Maroccia M, Becue F, Poitiers F, Swanson B, Cowan L, Sasiela WJ, Surks HK, Ginsberg HN. Effects of PCSK9 Inhibition With Alirocumab on Lipoprotein Metabolism in Healthy Humans. Circulation. 2017 Jan 24;135(4):352-362. doi: 10.1161/CIRCULATIONAHA.116.025253. Epub 2016 Dec 16.
PubMed 27986651
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Effects of Subcutaneous Doses of Alirocumab on Lipid and Lipoprotein Metabolism in Adults With Mildly Elevated LDL-Cholesterol
- ClinicalTrials.gov ID
- NCT01959971
- Acronym / sponsor ID
- PDY13670
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To assess the effects of subcutaneous (SC) doses of alirocumab on the elimination (measured by Fractional Clearance Rate (FCR)) of apolipoprotein B (apoB) in low density lipoprotein (LDL) in adults with mildly elevated LDL-cholesterol (LDL-C).
Secondary Objectives:
To assess the effects of SC doses of alirocumab on:
- Various parameters of the metabolism and turnover in plasma of different lipoproteins
- Plasma lipids concentration: total cholesterol, high density lipoprotein cholesterol (HDL-C), triglycerides, low density lipoprotein cholesterol (LDL-C), apoB, lipoprotein(a) (Lp(a))
- Lipoprotein particle size profile
- PCSK9 (free and total) concentrations in serum To assess safety and tolerability of alirocumab. To assess emergence of anti-alirocumab antibodies. To document serum alirocumab concentrations.
Detailed description
Total duration of the study per subject is 26 weeks, including a screening period of ≤ 4 weeks, placebo treatment period of 4 weeks, alirocumab treatment period of 10 weeks, and a follow up period of 8 weeks.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
- Model description
- Single-sequence crossover
| Arm | Type | Receives |
|---|---|---|
| Placebo - Alirocumab | Experimental | Drug: alirocumab, Drug: PlaceboInjection through subcutaneous (SC) administration, placebo for 4 weeks then, alirocumab for 10 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy; LDL-C level in serum or plasma ≥ 100 mg/dL and < 190 mg/dL at Screening.
Key exclusion criteria (3 listed)
- LDL-C ≥ 160 mg/dL at Screening if more than 2 major Coronary Heart Disease risk factors, as defined in National Cholesterol Education Program guidelines.
- Receiving treatment of any kind for hyperlipidemia within 6 weeks of enrollment.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| alirocumabAlso: SAR236553, REGN727, PraluentPharmaceutical form:Solution for injection Route of administration: Subcutaneous | Drug | Placebo - Alirocumab |
| PlaceboPharmaceutical form:Solution for injection Route of administration: Subcutaneous | Drug | Placebo - Alirocumab |
Primary outcome
Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment
Time frame: baseline and at 12 days after last dose of alirocumab
8 secondary outcomes
Change in lipids turnover parameters measured in isolated Very Low Density Lipoproteins (VLDL), Intermediate Density Lipoproteins (IDL), Low Density Lipoproteins (LDL) and High Density Lipoproteins (HDL)
Time frame: baseline and at 12 days after last dose of alirocumab
Change in post-heparin hepatic lipase and lipoprotein lipase activities
Time frame: baseline and at 2 days after last dose of alirocumab
Change in lipids and apolipoproteins in plasma lipids panel
Time frame: baseline and at 2 days and at 11 days after last dose of alirocumab
Assessment of Lipoprotein particle size profiles
Time frame: baseline and at 2 days and at 11 days after last dose of alirocumab
Assessment of serum concentrations of PCSK9
Time frame: baseline and up to 2 weeks after last dose of alirocumab
Assessment of safety parameters (clinical laboratory, ECG, vital signs)
Time frame: up to 10 weeks after last dose of alirocumab
Assessment of the serum concentration of alirocumab
Time frame: baseline and up to 2 weeks after last dose of alirocumab
Assessment of the serum concentration of anti-alirocumab antibodies
Time frame: baseline and up to 10 weeks after last dose of alirocumab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Results publication: PubMed 27986651Reyes-Soffer G, Pavlyha M, Ngai C, Thomas T, Holleran S, Ramakrishnan R, Karmally W, Nandakumar R, Fontanez N, Obunike J, Marcovina SM, Lichtenstein AH, Matthan NR, Matta J, Maroccia M, Becue F, Poitiers F, Swanson B, Cowan L, Sasiela WJ, Surks HK, Ginsberg HN. Effects of PCSK9 Inhibition With Alirocumab on Lipoprotein Metabolism in Healthy Humans. Circulation. 2017 Jan 24;135(4):352-362. doi: 10.1161/CIRCULATIONAHA.116.025253. Epub 2016 Dec 16.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing alirocumab in people with Hypercholesterolemia, run by Sanofi at 1 site in United States.
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 1 inclusion and 3 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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in Fractional Clearance Rate of apolipoprotein B (apoB) in Low Density Lipoproteins (pools/day) in plasma during alirocumab treatment (time frame: baseline and at 12 days after last dose of alirocumab). 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 NCT01959971, which also lists 1 linked publication.
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 2 May 2017.