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NCT ID: NCT06087835 Recruiting - Clinical trials for Chronic Kidney Disease With High Proteinuria

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Start date: November 7, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria.

NCT ID: NCT06087822 Recruiting - Clinical trials for Overweight or Obesity

Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®

SHINE
Start date: October 5, 2023
Phase: N/A
Study type: Interventional

The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.

NCT ID: NCT06082167 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

STELLAR-305
Start date: November 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.

NCT ID: NCT06079281 Recruiting - Hypophosphatasia Clinical Trials

Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa

HICKORY
Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

NCT ID: NCT06077864 Recruiting - Obesity Clinical Trials

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Start date: November 17, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.

NCT ID: NCT06073093 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

SPECIFI-RA
Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

NCT ID: NCT06072183 Recruiting - Clinical trials for Stable Nonsegmental Vitiligo

A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

Tranquillo 2
Start date: November 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who: - Are 18 years of age or older. - are confirmed to have nonsegmental vitiligo for at least 3 months. - Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments: •Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study. • In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as: - vitiligo rating, - physical examinations, - hearing tests, - blood tests, - x-ray, - ECG, - photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.

NCT ID: NCT06068114 Recruiting - Healthy Clinical Trials

Gastric Pathophysiology in Diabetes

DiaFLIP
Start date: October 5, 2022
Phase:
Study type: Observational [Patient Registry]

This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated. For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.

NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

NCT ID: NCT06059846 Recruiting - Clinical trials for Urinary Tract Infection

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

PIVOT-PO
Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.