Clinical trials: Processes, Metabolic
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Afrezza® Dosing Optimization Study
MKC-TI-191 is a Phase 4, single-arm, multicenter, proof-of-concept clinical trial evaluating the efficacy and safety of Afrezza, administered according to the current Afrezza prescribing information (PI) compared to a titrated…
- Trial name
- DOS (NCT04849845)
- Testing
- Afrezza Dose 1, Afrezza Dose 2
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Mannkind Corporation
Gout
Validation Study of Physical Measurement of Tophi
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
- Trial name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
Gout, Hyperuricemia
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
- Conditions
- Gout, Hyperuricemia, Arthritis, Joint Disease
- Trial name
- NCT01407874
- Testing
- Ulodesine (BCX4208) 5 mg, Ulodesine (BCX4208) 10 mg
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- BioCryst Pharmaceuticals
Gout, Hyperuricemia
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in…
- Trial name
- NCT04139824
- Testing
- Xanthine Oxidase Inhibitor, nonsteroidal anti-inflammatory drug
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Chronic Kidney Disease, Type 2 Diabetes Mellitus
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States
This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied.
- Trial name
- 22663 (NCT06608212)
- Testing
- Finerenone (Kerendia, BAY948862), Others except finerenone
- Where
- United States
- Volunteers
- 238,038 people
- Sponsor
- Bayer
Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury
Research on Wireless Brain Implant System for General Control of External Devices
The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive…
- Conditions
- Complete or Incomplete Paraplegia/quadriplegia, Spinal Cord Injury, Brainstem Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- RISE (NCT06829212)
- Testing
- WRS
- Where
- China
- Volunteers
- 4 people
- Sponsor
- Shanghai StairMed Technology Co., Ltd.
Diabetic Nephropathy, Type 2 Diabetes Mellitus
ORIENT: Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes Mellitus, Proteinuria
- Trial name
- NCT00141453
- Testing
- olmesartan medoxomil
- Where
- 2 sites in China, Japan
- Volunteers
- 577 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Hyperuricemia
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
- Trial name
- SAD (NCT04236219)
- Testing
- ALLN-346
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allena Pharmaceuticals
Hyperphosphatemia, Inflammation
An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.
- Conditions
- Hyperphosphatemia, Inflammation, Renal Disease
- Trial name
- NCT00834301
- Testing
- Oral Multivitamin
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Nephrian
Niemann-Pick Disease, Type C
Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease
Due to different study designs, the sponsor separated Part C into this separate registration (NCT04958642), leaving Parts A/B in NCT02534844.
- Trial name
- NCT04958642
- Testing
- Adrabetadex
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 66 people
- Sponsor
- Mandos LLC
Inflammation, Interleukin-1beta
Effect on Cytokines IL-1ß, TNF-α, IL-4, and Total Bacterial Load of a Composition Comprising Olive Oil, Trimethylglycine and Xylitol Delivered as a Toothpaste
The goal of this clinical trial is to learn if a novel composition comprising olive oil, trimethylglycine and xylitol, affects salivary levels of IL-1ß, TNF-α and IL-4 in a group of periodontally healthy, normal and…
- Conditions
- Inflammation, Interleukin-1beta, TNF-α, Cytokine Levels
- Trial name
- NCT06786910
- Testing
- Toothpaste with olive oil, trimethylglycine and xylitol, Toothpaste without olive oil, trimethylglycine nor xylitol
- Where
- Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Mucosa Innovations, S.L.
Gout
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208.
- Trial name
- NCT00985127
- Testing
- BCX4208
- Where
- 24 sites in United States
- Volunteers
- 99 people
- Sponsor
- BioCryst Pharmaceuticals
Non-Alcoholic Fatty Liver Disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo.
- Trial name
- MAESTRO-NAFLD1 (NCT04197479)
- Testing
- Resmetirom
- Where
- 77 sites in United States, Puerto Rico
- Volunteers
- 1,343 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Diabetes Mellitus
Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered…
- Trial name
- NCT00426920
- Testing
- Insulin
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- QDose Limited
Dehydration
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hydration status, including: 1) at various timepoints throughout a 24-hour period…
- Trial name
- NCT06212518
- Testing
- GENPOP ad libitum fluid intake, GENPOP fluid restriction, ATHLETE ad libitum fluid intake
- Where
- 4 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Homozygous Familial Hypercholesterolemia (HoFH)
Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients
This study is designed to help identify patients with HoFH due to mutations in the LDLR as confirmed by genotyping.
- Trial name
- NCT04148001
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- REGENXBIO Inc.
Hypoparathyroidism, Osteoporosis
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with modified oral formulations (EBP11, EBP11-F1, EBP11-F2, EBP11-F4, EBP11-F5 and EBP22) versus three dose levels of…
- Conditions
- Hypoparathyroidism, Osteoporosis, Fractures, Bone, Other Disease
- Trial name
- NCT05965167
- Testing
- EBP05, Forteo 0.02 mg, EBP11
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Entera Bio Ltd.
Gout, Arthritis, Gouty
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT05253833
- Testing
- AR882 Dose 1, AR882 Dose 2, Allopurinol Tablet
- Where
- 12 sites in United States, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Arthrosi Therapeutics
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with…
- Trial name
- NCT07210021
- Testing
- AK+ Guard™ ECG Application
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AccurKardia, Inc.
Dehydration
Subcutaneous Rehydration Compared to Intravenous Rehydration
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
- Trial name
- PEDs-II (NCT00773175)
- Testing
- recombinant human hyaluronidase
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Halozyme Therapeutics