Search for a trial

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.

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.…

Acute Nutritional Ketosis in VLCAD Deficiency: testing the metabolic basis for therapeutic use

To test if acute NK boosts muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder. A secondary objective is to gather data to test the working hypothesis that the…

Novel Approach to Detect the Detailed Effects of Vildagliptin on Beta-cell
Dynamics in Patients with Early-onset Type 2 Diabetes

PrimaryThe 3 months* effect of Vildagliptin on insulin synthesis and storage capacitySecondaryThe 3 months* effect of vildagliptin on- Glucose, insulin, C-peptide levels- Hormonal axes, most importantly GLP1 and GIP and Glucagon- Body weight, body…

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, double-blind, parallel group study to evaluate metabolic effects of LCZ696 and amlodipine in obese hypertensive subjects: the CLCZ696B2207 study

The objective of this study is to investigate what the effects of LCZ696 or amlodipine are on insulin sensitivity as assessed by hyperinsulinemic euglycemic glucose clamp (HEGC) after 8 weeks of treatment. Furthermore, the effects on subcutaneous…

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…

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…

DALI: Vitamin D and Lifestyle Intervention for GDM Prevention: dosing study

The overall aim of the DALI study is to identify the best available measures to prevent GDM in an ongoing pregnancy, to provide a cost-benefit calculation of GDM prevention for health care systems, and to establish a pan-European cohort of mother-…

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…

A Phase 2A, Double-blind, Placebo-controlled, Randomized
Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male patients with increased Cardiometabolic Risk

To determine the safety and efficacy (in increasing insulin sensitivity) of TRC 150094 once daily dosing for 4 weeks in male subjects with increased cardiometabolic risk.To evaluate the effect of TRC150094 on hepatic fat and metabolic parameters.To…

Evaluation of the Glucoregulatory Effects of GLP-1 Receptor Activation in Patients with Type 2 Diabetes Mellitus

Primary:to assess the glycemic effects of a single dose of OXM on the ambient glucose levels during a GGI assessmentto assess the insulinotropic effects of a single dose of OXM measured as a change in "*" during a GGI assessmentSecondary:…

A double-blind, placebo-controlled, randomized trial to study the Viaskin® Peanut*s Efficacy and Safety for treating peanut allergy in children and adults.

· To determine the efficacy of several doses of Viaskin® Peanut to significantlydesensitize peanut-allergic subjects to peanut after 12 months of EPIT treatment .· To evaluate the safety of a long-term EPIT with Viaskin® Peanut.

A randomized double blind placebo controlled study on the effects of fenretinide Lym-X-Sorb on insulin sensitivity in obese insulin resistant subjects

Primary objective:To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjectsSecondary objective:To assess the effects of fenretinide on hepatic steatosis, body weight and body fat…