MedPath

Aleglitazar

Generic Name
Aleglitazar
Drug Type
Small Molecule
Chemical Formula
C24H23NO5S
CAS Number
475479-34-6
Unique Ingredient Identifier
41T4OAG59U
Background

Aleglitazar is an investigational drug from the company Hoffmann–La Roche and is currently in a phase III clinical trial called ALECARDIO. It is being investigated for use in patients with type II diabetes to reduce their risks of cardiovascular mortality and morbidity. Aleglitazar is an agonist at the peroxisome proliferator-activated receptor (PPAR) for both the PPARα and PPARγ receptor subtypes. In the phase II clinical trial called SYNCHRONY, with type II diabetic patients, aleglitazar was able to control both lipid and glucose levels in a synergistic manner while also having limited side effects and toxicity.

Indication

Investigated for use in patients with type II diabetes to reduce their risks of cardiovascular mortality and morbidity.

A Study of Alegitazar in Patients With Type 2 Diabetes And Chronic Kidney Disease (Alerenal Study)

Phase 3
Withdrawn
Conditions
Diabetes Mellitus Type 2, Kidney Disease, Chronic
Interventions
Drug: Placebo
First Posted Date
2013-07-08
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Registration Number
NCT01893242

A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: placebo
First Posted Date
2013-06-06
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
13
Registration Number
NCT01871428

A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
First Posted Date
2013-06-06
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
7
Registration Number
NCT01871415

A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin

Phase 2
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
First Posted Date
2012-11-20
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
57
Registration Number
NCT01729403

A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

Phase 3
Completed
Conditions
Cardiovascular Disease, Diabetes Mellitus Type 2
Interventions
Drug: Placebo
First Posted Date
2012-10-29
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1999
Registration Number
NCT01715818

A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2012-10-22
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
16
Registration Number
NCT01711775

A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteer
Interventions
First Posted Date
2012-10-05
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
28
Registration Number
NCT01701739

A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: Placebo
First Posted Date
2012-09-25
Last Posted Date
2016-08-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
196
Registration Number
NCT01691755

A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy

Phase 3
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: placebo
First Posted Date
2012-09-25
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
197
Registration Number
NCT01691989

A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease

Phase 2
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: placebo
First Posted Date
2012-09-07
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
18
Registration Number
NCT01680978
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