Dyslipidemia

Metabolic Diseases
29
Pipeline Programs
16
Companies
50
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
6
1
12
1
5
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
360%
Small Molecule
240%
+ 33 programs with unclassified modality

On Market (2)

Approved therapies currently available

Regeneron
PRALUENTApproved
alirocumab
Regeneron
PCSK9 Inhibitor [EPC]injection2015
Amgen
REPATHAApproved
evolocumab
Amgen
PCSK9 Inhibitor [EPC]injection2015

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
3 programs
1
1
FluvastatinPhase 4Small Molecule5 trials
TAP311Phase 11 trial
Real World Adherence of PCSK9 Targeted TherapyN/A1 trial
Active Trials
NCT07468500Not Yet Recruiting3,600Est. Jul 2026
NCT01487460Completed137Est. Jun 2012
NCT01681199Unknown140Est. Aug 2014
+4 more trials
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
2
1
EvolocumabPhase 3Monoclonal Antibody1 trial
EvolocumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT02207634Completed1,974Est. Nov 2016
NCT02867813Completed5,035Est. Mar 2022
Regeneron
RegeneronTARRYTOWN, NY
1 program
1
AlirocumabPhase 4Monoclonal Antibody
Abbott
AbbottABBOTT PARK, IL
4 programs
1
2
ABT-335 and rosuvastatin calciumPhase 31 trial
Fixed Combination of Fenofibrate/simvastatin 145/20 mgPhase 31 trial
AtorvastatinPhase 2Small Molecule4 trials
My A:careN/A1 trial
Active Trials
NCT05370703Completed150Est. Nov 2022
NCT00728910Completed25Est. Aug 2009
NCT00681525Completed18
+4 more trials
Sanofi
SanofiPARIS, France
1 program
1
RimonabantPhase 35 trials
Active Trials
NCT00754689Withdrawn0Est. Nov 2008
NCT00690456Terminated403Est. Feb 2009
NCT00678483Terminated331Est. Feb 2009
+2 more trials
Veloxis Pharmaceuticals
2 programs
1
1
LCP-AtorFenPhase 2/31 trial
LCP-AtorFenPhase 21 trial
Active Trials
NCT00504829CompletedEst. Jul 2008
NCT00664859CompletedEst. Feb 2009
M&
Merck & Co.RAHWAY, NJ
5 programs
4
1
MK0354Phase 21 trial
MK0524BPhase 11 trial
anacetrapibPhase 11 trial
fenofibratePhase 11 trial
niacinPhase 11 trial
Active Trials
NCT00943124Completed220Est. Aug 2007
NCT00990808Completed46Est. Jul 2011
NCT00928694Completed14Est. Apr 2004
+2 more trials
Akros Pharma
Akros PharmaNJ - Princeton
4 programs
4
JTT-302Phase 21 trial
JTT-302Phase 21 trial
JTT-705 600 mg and atorvastatin 20 mgPhase 21 trial
JTT-705 600 mg and simvastatin 40 mgPhase 21 trial
Active Trials
NCT00748852Completed103Est. Mar 2008
NCT00749788Completed150Est. Feb 2008
NCT00689442Completed105Est. Mar 2006
+1 more trials
Pfizer
PfizerNEW YORK, NY
2 programs
1
CP-778,875Phase 21 trial
Patient ComplianceN/A1 trial
Active Trials
NCT00673660Completed375Est. Oct 2009
NCT00326326Completed84Est. Jun 2007
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
1
PPAR alphaPhase 21 trial
EvacetrapibPhase 11 trial
Active Trials
NCT02168803Completed101Est. Dec 2015
NCT00116519Completed300Est. Oct 2006
R
ResVerlogiXAB - Calgary
2 programs
1
1
RVX000222Phase 21 trial
RVX000222Phase 1/21 trial
Active Trials
NCT00768274Completed72Est. Aug 2009
NCT01863225Terminated13Est. Jun 2013
Ipsen
IpsenChina - Tianjin
1 program
1
A3309Phase 21 trial
Active Trials
NCT01069783Completed36Est. Sep 2010
NewAmsterdam Pharma
NewAmsterdam PharmaNARRDEN, Netherlands
1 program
1
ObicetrapibPhase 21 trial
Active Trials
NCT05421078CompletedEst. Apr 2023
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
5 programs
Crestor RUSH (The Efficacy of RosUvaStatin for Korean Dyslipidemia Patients With Hypertension )N/A1 trial
Dyslipidemia Treatment in Thailand and Cardiovascular OutcomesN/A1 trial
Hs-CRP as Clinical Marker of Inflammatory Atherogenic DyslipidemiaN/A1 trial
Management of Dyslipidemia in Adult Type 2 Diabetes Patients in IndiaN/A1 trial
Study of Undertreatment of Patients With Dyslipidemia in BulgariaN/A1 trial
Active Trials
NCT00526708Completed5,000Est. Nov 2007
NCT01265836Withdrawn1,064Est. Mar 2013
NCT00169871Completed1,000Est. Dec 2006
+2 more trials
DS
Daiichi SankyoChina - Shanghai
2 programs
MevalotinN/A1 trial
Non-interventionalN/A1 trial
Active Trials
NCT05120895Completed3,060Est. Dec 2024
NCT04271280Completed9,559Est. Apr 2022
Pulse Biosciences
Pulse BiosciencesCA - Hayward
1 program
Dietary pulsesN/A1 trial
Active Trials
NCT01594567UnknownEst. Dec 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
NovartisFluvastatin
NovartisFluvastatin
NovartisFluvastatin
NovartisFluvastatin
NovartisFluvastatin
NovartisFluvastatin
NovartisFluvastatin
NovartisFluvastatin
AmgenEvolocumab
AmgenEvolocumab
AbbottFixed Combination of Fenofibrate/simvastatin 145/20 mg
SanofiRimonabant
SanofiRimonabant
SanofiRimonabant
SanofiRimonabant

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 55,616 patients across 50 trials

NCT01681199NovartisFluvastatin

Fluvastatin AmelIorates aTHerosclerosis Study

Start: Jul 2012Est. completion: Aug 2014140 patients
Phase 4Unknown
NCT01551173NovartisFluvastatin

Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Start: Jan 2012Est. completion: May 2013436 patients
Phase 4Completed
NCT00385658NovartisFluvastatin

Efficacy of Fluvastatin and Fenofibrate in Comparison to Simvastatin and Ezetimibe in Patients With Metabolic Syndrome

Start: Aug 2006Est. completion: Mar 200775 patients
Phase 4Completed
NCT00125125NovartisFluvastatin

Fluvastatin in Adults With Dislipidemia With History of Muscle Problems

Start: May 2005Est. completion: Dec 2005218 patients
Phase 4Completed
NCT00138528NovartisFluvastatin

Other Effects of Fluvastatin Are Investigated in Patients With Metabolic Syndrome

Start: Oct 2004Est. completion: Feb 200655 patients
Phase 4Completed
NCT00171262NovartisFluvastatin

Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers

Start: Aug 2004Est. completion: Jun 2007120 patients
Phase 4Completed
NCT00171275NovartisFluvastatin

Fluvastatin in the Therapy of Acute Coronary Syndrome

Start: Nov 20031,000 patients
Phase 4Completed
NCT00565474NovartisFluvastatin

Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant

Start: Sep 200184 patients
Phase 4Completed
NCT02867813AmgenEvolocumab

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

Start: Sep 2016Est. completion: Mar 20225,035 patients
Phase 3Completed
NCT02207634AmgenEvolocumab

Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects

Start: Sep 2014Est. completion: Nov 20161,974 patients
Phase 3Completed
NCT01674712AbbottFixed Combination of Fenofibrate/simvastatin 145/20 mg

A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease

Start: Jun 2012Est. completion: Oct 2013575 patients
Phase 3Completed
NCT00754689SanofiRimonabant

Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

Start: Sep 2008Est. completion: Nov 20080
Phase 3Withdrawn
NCT00690456SanofiRimonabant

Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes

Start: May 2008Est. completion: Feb 2009403 patients
Phase 3Terminated
NCT00678483SanofiRimonabant

Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients

Start: Apr 2008Est. completion: Feb 2009331 patients
Phase 3Terminated
NCT00577148SanofiRimonabant

An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes

Start: Feb 2008Est. completion: Feb 200989 patients
Phase 3Terminated
NCT00576667SanofiRimonabant

An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes

Start: Jan 2008Est. completion: Feb 2009165 patients
Phase 3Terminated
NCT00465088AbbottAtorvastatin

An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

Start: Apr 2007199 patients
Phase 3Completed
NCT00478972SanofiRimonabant

Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise

Start: Apr 2007Est. completion: Jan 2009321 patients
Phase 3Terminated
NCT00458081SanofiRimonabant

Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors

Start: Mar 2007Est. completion: Jan 2009174 patients
Phase 3Terminated
NCT00449605SanofiRimonabant

A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

Start: Mar 2007Est. completion: Mar 2009508 patients
Phase 3Terminated
NCT00434096SanofiRimonabant

Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

Start: Feb 2007Est. completion: Feb 2009915 patients
Phase 3Terminated
NCT00405808SanofiRimonabant

Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose

Start: Dec 2006Est. completion: Feb 20092,666 patients
Phase 3Terminated
NCT00408148SanofiRimonabant

High Density Lipoprotein Turnover

Start: Oct 2006Est. completion: Dec 200864 patients
Phase 3Terminated
NCT00382161NovartisFluvastatin

Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors

Start: Oct 2006Est. completion: Dec 200720 patients
Phase 3Withdrawn
NCT00300430AbbottABT-335 and rosuvastatin calcium

Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

Start: Sep 20061,911 patients
Phase 3Completed
NCT00325650SanofiRimonabant

Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes

Start: May 2006Est. completion: Mar 20092,420 patients
Phase 3Terminated
NCT00325546SanofiRimonabant

Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)

Start: Apr 2006Est. completion: Apr 2007643 patients
Phase 3Completed
NCT00299325SanofiRimonabant

VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt

Start: Feb 2006Est. completion: Jul 2008254 patients
Phase 3Completed
NCT00288236SanofiRimonabant

Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)

Start: Jan 2006Est. completion: Jul 2007368 patients
Phase 3Completed
NCT00263042SanofiRimonabant

Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Start: Dec 2005Est. completion: Apr 200918,695 patients
Phase 3Terminated
NCT00228176SanofiRimonabant

Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant

Start: Aug 2005Est. completion: Apr 2009661 patients
Phase 3Terminated
NCT00136799NovartisFluvastatin

Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

Start: Jun 2005Est. completion: Apr 2006325 patients
Phase 3Completed
NCT00239967SanofiRimonabant

An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients

Start: May 2005Est. completion: Feb 2007803 patients
Phase 3Completed
NCT00257257SanofiRimonabant

Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients

Start: Mar 2005Est. completion: Jun 2006281 patients
Phase 3Completed
NCT00124332SanofiRimonabant

STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)

Start: Jan 2005Est. completion: Oct 2007839 patients
Phase 3Completed
NCT00458718SanofiRimonabant

Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch

Start: Sep 2004Est. completion: Jul 2005755 patients
Phase 3Completed
NCT00195793AbbottAtorvastatin

A 16 Week Comparative Study of Fenofibrate Versus Ezetimibe as Add-on Therapy to Atorvastatin

Start: Aug 2004174 patients
Phase 3Completed
NCT00481975SanofiRimonabant

Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

Start: Aug 2004Est. completion: Aug 2005289 patients
Phase 3Completed
NCT00481923SanofiRimonabant

Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients

Start: May 2004Est. completion: Apr 2005156 patients
Phase 3Completed
NCT00464256SanofiRimonabant

Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation

Start: Apr 2004Est. completion: Nov 2004533 patients
Phase 3Completed
NCT00171288NovartisFluvastatin

Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Start: Aug 2003Est. completion: Aug 200583 patients
Phase 3Completed
NCT00464165SanofiRimonabant

Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

Start: Nov 2002Est. completion: Oct 2003789 patients
Phase 3Completed
NCT00459173SanofiRimonabant

Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation

Start: Nov 2002Est. completion: Sep 20054,850 patients
Phase 3Completed
NCT00171236NovartisFluvastatin

Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

Start: Oct 2001Est. completion: Mar 200584 patients
Phase 3Completed
NCT00029848SanofiRimonabant

Obese Patients With Type 2 Diabetes

Start: Oct 2001Est. completion: May 20041,045 patients
Phase 3Completed
NCT00029835SanofiRimonabant

Obese Patients With Untreated Dyslipidemias

Start: Sep 2001Est. completion: Nov 20031,033 patients
Phase 3Completed
NCT00029861SanofiRimonabant

Obese Patients With or Without Comorbidities (RIO-North America)

Start: Aug 2001Est. completion: Apr 20043,045 patients
Phase 3Completed
NCT00664859Veloxis PharmaceuticalsLCP-AtorFen

12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

Start: Oct 2007Est. completion: Feb 2009
Phase 2/3Completed
NCT05421078NewAmsterdam PharmaObicetrapib

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Start: Jun 2022Est. completion: Apr 2023
Phase 2Completed
NCT01863225ResVerlogiXRVX000222

Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia

Start: May 2013Est. completion: Jun 201313 patients
Phase 2Terminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
16 companies competing in this space

Related Indications

Diabetes(737)Diabetes Mellitus, Type 2(485)Obesity(246)Type 2 Diabetes(207)Type 2 Diabetes Mellitus(190)Diabetes Mellitus(127)Diabetes Mellitus, Type 1(95)Type 1 Diabetes Mellitus(51)Type 1 Diabetes(50)Gout(36)