21 results
Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…
To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…
The main objective of this study is to assess incidence of, clinical determinants for, dose reduction in and reversibility of tenofovir associated renal insufficiency and KPTD.Secondary objectives are to assess kidney tubular function in patients…
To compare the effect of semaglutide 1.0 mg once-weekly versus exenatide extended release (ER) 2.0 mg once-weekly on glycaemic control after 56 weeks of treatment.
To compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
Primary objective:To compare the effect of semaglutide subcutaneous (s.c.) once daily versus placebo on histological resolution of non-alcoholic steatohepatitis (NASH). Secondary efficacy objectivesTo investigate the dose-response relationship of…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
The purpose of this study is to investigate if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 2 different products, semaglutide and dulaglutide, in healthy volunteers. The 2 products…
Primary objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of…
The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.
The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria.
The primary objective of the study is to determine the safety and tolerability of 4 week oral administration of EYP001a in subjects with Chronic Hepatitis B Virus Infection (CHBV) when given as monotherapy or in combination with Pegylated interferon…
To study the effect of type 2 diabetes (T2D) on vascular wall inflammatory macrophage accumulation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed by drastically improving metabolic control, using potent…
Primary objectiveTo investigate the effects of semaglutide s.c. 2.4 mg once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesityrelated HFpEF.Secondary objectivesTo…
Primary objectiveTo investigate the effects of semaglutide s.c. 2.4 mg once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.Secondary…
The primary objective-To demonstrate that semaglutide 2.4 mg once weekly lowers the incidence risk of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in patients with established CV disease and…
Primary: to confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular event (MACE). Secondary: to confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time…
The primary objective is to demonstrate that semaglutide delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo, both added to standard-of-care, in subjects with type 2 diabetes and…
Primary To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus placebo as adjuncts to reduced-calorie diet andincreased physical activity in participants with overweight or obesity. Secondary To confirm superiority of…
Primary objectivesThe trial has two parts, a part 1 and a part 2, with distinctive objectives and endpoints.Part 1 of the trial: To demonstrate that treatment with semaglutide s.c. improves liver histology compared to placebo in subjects with NASH…