Phase 3
N=233
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT02023879 ↗Enrolled (actual)
233
Serious AEs
17.2%
Results posted
Mar 2017
Primary outcome: Primary: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) — 4.7; -53.5; -51.7 percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Alirocumab (Drug); Placebo (for Alirocumab) (Drug); Non-statin LMT (Drug); Diet Alone (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis) |
4.7; -53.5; -51.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis |
5.1; -55.3; -54.6 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
3.2; -50.8; -41.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis |
3.6; -51.5; -44.8 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis |
3.2; -53.6; -52.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis |
3.6; -54.1; -55.0 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis |
7.5; -39.7; -38.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis |
7.7; -41.2; -40.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis |
4.8; -45.3; -44.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis |
5.0; -46.9; -46.7 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 24 - ITT Analysis |
3.0; -34.0; -32.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Apo B at Week 12 - ITT Analysis |
7.0; -38.4; -31.3 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis |
3.0; -43.4; -34.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total-C at Week 12 - ITT Analysis |
1.8; -32.6; -24.5 | <0.0001 sig |
| SECONDARY Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis |
1.8; 70.3; 63.9 | <0.0001 sig |
| SECONDARY Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis |
1.8; 72.7; 67.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis |
0.0; 60.0; 50.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis |
0.0; 61.7; 50.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis |
4.1; -21.8; -15.5 | 0.0002 sig |
| SECONDARY Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis |
2.2; -16.5; -5.7 | 0.0892 |
| SECONDARY Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis |
-2.4; 7.4; 7.7 | — |
| SECONDARY Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis |
-0.8; 6.8; 8.6 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis |
1.1; -10.6; -9.2 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis |
2.1; -11.3; -3.0 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis |
3.4; 8.2; 10.0 | — |
| SECONDARY Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis |
2.6; 5.9; 7.6 | — |
Summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin.
Secondary Objective:
* To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo.
* To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.
Alirocumab 75 mg Q2W was added as a calibrator arm.
Eligibility Criteria
Inclusion criteria
Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or fenofibrate) or diet alone.
Exclusion criteria
- LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very high cardiovascular (CV) risk;
- LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at high or moderate CV risk or, participants not fulfilling the statin intolerant definition at moderate CV risk;
- LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or, participants not fulfilling the statin intolerant definition at moderate CV risk and receiving a non-statin LMT.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02023879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.