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Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Polycystic Ovarian Syndrome

The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…

FAST * Food Allergy Specific ImmunoTherapy
A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish

To evaluate the efficacy and safety of a SCIT-treatment with a mutant recombinant fish-parvalbumin (mCyp c1) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

Metformin and sitagliptin in patients with impaired glucose tolerance and a recent TIA or minor ischemic stroke - safety and feasibility

We aim to compare the effectiveness, feasibility and safety of both metformin and sitagliptin in patients with TIA or minor ischemic stroke and impaired glucose tolerance. Furthermore, we will assess whether a slow increase in dose of metformin over…

A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of volanesorsen Administered Subcutaneously to Patients with Familial Partial Lipodystrophy

Primary Objective:To evaluate the efficacy of volanesorsen for reduction in severity of metabolic derangement in patients with FPL with hypertriglyceridemia and uncontrolled diabetes.Secondary Objectives:To evaluate the safety and tolerability of…

A Randomized, Double Blind, Placebo-Controlled, Dose Titration, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 494372 Administered Subcutaneously to Patients with High Lipoprotein(a)

Primary Objectives:-To characterize the safety and tolerability of ISIS 494372 in individual patients at escalating doses of 100, 200, and 300 mg/week-To characterize the efficacy of ISIS 494372 in lowering Lp(a) using a dose titration study design.…

Dosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome treated with oral Eubacterium hallii

To investigate different dosages of 4 weeks oral Eubacterium hallii treatment on safety and efficacy parameters.

An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)

The primary objectives of this study are: • To determine the longterm safety and tolerability of rhHNS administered via an intrathecal (IT) route once monthly for 8 years in patients with MPS IIIA, who have received and tolerated 6 months of…

A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects with Type 2 Diabetes Mellitus

The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.The primary safety objective of this study is to evaluate the…

A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

Primary Objectives•To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed…

Protein and lifestyle intervention to preserve muscle mass in obese older type 2 diabetes patients - a 13-week randomised, controlled exploratory study with a 24-week follow-up period.

Primary: To investigate the effect on leg muscle mass in the test group compared to the control group in older obese type 2 diabetes patients after 13 weeks of interventionSecondary: - To investigate the effect on glycemic control in the test group…

A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels

The primary objectives of the study are the following:* To assess the dose response of the following parameters:* Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12* Percent change in TG from baseline to…

A Randomized, Multicenter, Phase II study to Investigate Efficacy and Safety of ITF2984 in Acromegalic patients.

- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…

Multicenter, Controlled, Open-Label Extension (OLE) Study To Assess the Long-Term Safety and Efficacy of AMG 145 (study 20110110)

Primary: Longterm safety and tolerability of AMG 145.Secondary: Longterm efficacy of AMG 145.

A randomized, double-blind, double-dummy, multi-center study to assess safety and efficacy of BAY 94-8862 in subjects with emergency presentation at the hospital because of worsening chronic heart failure with left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or moderate chronic kidney disease alone versus eplerenone

Primary objective of the study is• To investigate efficacy and safety of different oraldoses of BAY94-8862 given once daily over 90 daysThe secondary objectives are:•To assess the effects of these doses on a compositeendpoint of death from any cause…

A Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).
A Multicentre, Randomized, Double Blind, Placebo-Controlled study, with an adaptive design to allow for initial GFT505 80mg dosing versus placebo, followed by a second phase including GFT505 120mg dose, after review of 6-month safety analysis of the 80mg data on at least 50% of patients.

The primary objectives of this study are: - To evaluate the efficacy of GFT505 80mg and GFT505 120mg once daily (according to adaptive design, after 6-month interim safety analysis of the 80mg data on at least 50% of patients) for 52 weeks versus…

Open-label follow-up study of the VIPES study to evaluate long-term efficacy and safety of the Viaskin Peanut

The objectives of this follow-up/extension study of the VIPES study are:• To assess the efficacy of Viaskin® Peanut after up to 36 months of Epicutaneous Immunotherapy (EPIT) in peanut-allergic subjects.• To evaluate the safety of long-term…

A 20-week, double-blind, randomized, placebo-controlled, parallel-group trial to assess the safety and efficacy of HM11260C on body weight in obese subjects without diabetes

Primary objective• To assess the effect of HM11260C, in combination with a hypocaloric diet, on body weight over the 20 weeks from baseline in obese subjectsSecondary objectives• To assess the safety, tolerability, and immunogenicity of HM11260C, in…

A Randomized, Controlled, Open-label, Multicenter, Phase IIb
Safety and Efficacy Study of HGT-1410 (Recombinant Human
Heparan N Sulfatase) Administration via an Intrathecal Drug
Delivery Device in Pediatric Patients with Early Stage
Mucopolysaccharidosis Type IIIA Disease

The primary objective of this study is to assess the potential clinical efficacy of HGT-1410administered via a surgically implanted IDDD in patients with MPS IIIA. Efficacy will bemeasured as a meaningful amelioration in the progression of cognitive…

A Phase I/II Safety, Tolerability, Ascending Dose and Dose Frequency Study of Recombinant Human Heparan-N-sulfatase (rhHNS) Intrathecal Administration via an Intrathecal Drug Delivery Device in Patients With Sanfilippo Syndrome Type A (MPS IIIA)

The primary objectives of this study is:* To determine the safety and tolerability of rhHNS via ascending doses administered via a surgically implanted intrathecal drug device (IDDD) once monthly for 6 months, in patientswith MPS IIIA.The secondary…

A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination with Atorvastatin, Simvastatin, and Rosuvastatin in Patients with Hypercholesterolemia or Low HDL-C.

The primary objective of this study is to determine whether LY2484595, administered incombination with atorvastatin for 12 weeks to patients with hypercholesterolemia or low HDL-C, will significantly increase mean HDL-C and decrease mean LDL-C from…