233 results
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…
The primary aim of this RCT is to evaluate whether the use of oral supplementation of hydrolysed collagen/vitamin C in addition to usual care (education, load management and PTLE) is superior to usual care and placebo on VISA-P score after 24 weeks…
Primary objective To investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and FOS with and without conditioned vegan LFMT capsules to reduce NASH in patients with fibrotic NASH…
To attenuate the impact and duration of delayed graft funtion by dampening schemia reperfusion injury
The DAPARHT trial is designed to assess effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) weight, ii) glucose…
The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line mPDAC.This study aims to explore whether blockade of Transforming…
To evaluate the pharmacodynamic (PD) effects of daridorexant 25mg, 50mg, and placebo in the middle-of-the-night.
Part AMain objectives: • To evaluate the safety and tolerability of single intrathecal (IT) doses of ALN-APP in adult patients with EOADPart BMain objectives:• To evaluate the safety and tolerability of multiple IT doses of ALN-APP in adult patients…
Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…
Primary objective:- To evaluate the efficacy, including clinical remission and endoscopic response, of guselkumab SC inductionSecondary objectives:- To evaluate the efficacy of guselkumab SC across a range of outcome measures- To evaluate the safety…
The main aim of this study is to assess whether protein supplementation could prevent excessive fat free mass loss during the first year after bariatric surgery.
PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17 year-olds) with chronic migraineSecondary* To compare galcanezumab with placebo with respect to 50% response…
In this study we will investigate how safe the experimental compounds AER001 and AER002 are and how well they are tolerated when they are used in healthy subjects.We also investigate how quickly and to what extent AER002 (as a single dose) and…
In this study we will investigate how safe the new compound MT1980 is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent MT1980 is absorbed, transported, and eliminated from the…
To investigate effect of a single dose of MK-1167 on glutamate levels in the brain using MRS. Glutamate is a chemical that sends signals between nerve cells in the brain. To test the safety and tolerability of single oral doses of the trial drug, MK…
To determine the efficacy of treatment with mitapivat compared with placebo, as assessed by the reduction in transfusion burden in pediatric subjects with pyruvate kinase deficiency (PK deficiency) who are regularly transfused.
Core phase: The overall objective of the core phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1), administered once daily (QD) or twice…
Objective: Primary Aim (PHASE 1):To determine the prevalence of RLS in women with ALD.Secondary Aim (PHASE 2):To determine whether in a blinded crossover study a 8-week pramipexole treatment course will significantly reduce RLS symptoms compared to…
This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess theefficacy and safety of CDR132L in patients with reduced LVEF (<= 45%) after MI.Primary:To assess the efficacy of 2 dose levels (5 and 10 mg/kg…
Primary objective:- To evaluate the anti-tumor efficacy of HLX10 in combination with chemotherapy and concurrent radiotherapy in subjects with LS-SCLCSecondary objectives:- To evaluate the safety of HLX10 in combination with chemotherapy and…