Clinical Research Directory

A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia

This study will evaluate an investigational drug called NNC4004-0002. "Investigational" means NNC4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. Its use in this study is experimental. This will be the first time that NNC4004-0002 will be given to human. This study will be testing the ability of the study medicine to lower serum uric acid. The main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. Participants will either get NNC4004-0002 (the study medicine), or saline. Which treatment the participant get will be decided by chance. The participant will get the medicine as an injection under their skin. Depending on the dose they will receive, participant may need more than one injection. The study will last for about 19 months in total. The participant will take part in the study for about 7 months. Participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.

Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks

This is a nationwide, multi-center, long-term follow-up study of overweight and obese adults in China. The study aims to recruit approximately 26,000 participants across 39 hospitals to better understand how body weight affects the development of obesity-related diseases over a 3-year period. Eligible participants are adults aged 18 to 79 years with a body mass index (BMI) of 23 kg/m² or higher. Participants will be grouped into four categories based on their BMI: overweight, mild obesity, moderate obesity, and severe obesity. At the beginning of the study, all participants will undergo a comprehensive health assessment, including physical measurements, body composition analysis, blood tests, and lifestyle questionnaires. Participants will then be followed for 3 years with annual check-ins to track any new health conditions. The main goal is to identify the 3-year risk of developing conditions such as type 2 diabetes, fatty liver disease, high blood pressure, and heart disease in different weight groups. This information will help doctors better predict and prevent obesity-related health problems in the future. Participation is voluntary, and all personal information will be kept confidential.

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With Hyperuricemia

This randomized study was designed to compare how well allopurinol and febuxostat lowered blood uric acid in adults with chronic kidney disease and high uric acid levels. It was planned to include 66 participants, aged 18 to 65 years, with stage 3 to 5 chronic kidney disease. Participants were to be assigned to receive either febuxostat 40 mg daily or allopurinol at a dose adjusted for their level of kidney function. Treatment was planned for eight weeks, with follow-up visits at weeks 4 and 8. The researchers hypothesized that the two medicines would differ in their effects after eight weeks. The main measure was the proportion of participants whose uric acid level reached below 6.0 mg/dL. Changes in uric acid levels and estimated kidney function were also to be compared.

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout

The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.

Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout

The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.

Mazdutide for Weight Management and Gout in Adults With Obesity

This is a single-arm, open-label, pre-post controlled study to evaluate the effect of Mazdutide on the annualized flare rate (AFR) in adults with obesity and gout. The study will enroll 30 subjects aged 18 to 65 years with a Body Mass Index (BMI) ≥ 30.0 kg/m². Eligible participants must have a confirmed diagnosis of gout and a history of at least 2 gout flares in the past 6 months. The primary objective is to compare the AFR during the 52-week treatment period with the 12 months prior to treatment. All subjects will receive Mazdutide with a dose-escalation regimen, and their outcomes will be compared to their own baseline data.

Uric Acid Lowering Trial in Youth Onset T2D

Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D. Accordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed \<21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.

Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss

Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism. A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.

Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia

A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to evaluate the effect of dotinurad, as monotherapy and in combination with allopurinol, versus allopurinol monotherapy, on the PK of each, and to assess the additive PD effects on serum uric acid and urinary urate excretion in U.S. patients with gout and hyperuricemia

Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients

This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase). Failed uricase treatment is defined as having an inherent intolerance, anaphylaxis, infusion reaction, antibody development, and/or at least one sUA level that rose to greater than 6 mg/dL while on therapy.

Chronic Kidney Disease and Metabolic Disorders in the Elderly

The goal of this observational study is to investigate the impact of metabolic comorbidities on outcomes in elderly Chinese adults, through two parallel sub-cohorts: one comprising elderly individuals without chronic kidney disease (CKD) at baseline, and one comprising elderly patients with established CKD. The main questions it aims to answer are: Do metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) increase the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality in elderly individuals without CKD at baseline? What are the optimal diagnostic thresholds and criteria for CKD in the elderly population? How do metabolic comorbidities affect long-term outcomes - including all-cause mortality, end-stage renal disease (ESRD), and cardiovascular events - in elderly patients with established CKD? What is the comorbidity profile and disease burden of elderly CKD patients in China? Participants in both sub-cohorts will: Undergo baseline assessments including laboratory tests and clinical evaluations. Provide longitudinal follow-up data through scheduled clinic visits and medical record linkage. Contribute to a large-scale cohort of 100,000 elderly participants across multiple centers in China.

Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support Tools in the Management of Patients With "Four Highs" (Hypertension, Hyperglycemia, Hyperlipidemia, Hyperuricemia)

This study conducted a six-month exploratory clinical trial to evaluate the impact of an exercise prescription mini-program, based on the "Exercise Guidelines for the 'Four Highs'", on the physical activity levels and related health indicators of patients with hypertension, hyperglycemia, hyperlipidemia, and hyperuricemia in primary healthcare settings in China.

Treat-to-target by Email During Urate-lowering Therapy in Gout

Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance. In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results. The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.

A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease

This is a phase I/II clinical study to evaluate the safety, tolerability, PK, and efficacy of IG3018 tablet in hyperuricemia (HUA) subjects with or without CKD.

Is There a Relationship Between Uric Acid Level and Liver Fibrosis in Obese Patients

1. Identifying the association between hyperuricemia and NAFLD can lead to early detection and prevention of liver fibrosis in adult obese patients. 2. Understanding the relationship between hyperuricemia and NAFLD can inform targeted therapy, such as urate-lowering treatment, to potentially slow disease progression. 3 - To examine the relationship between serum uric acid levels and liver fibrosis severity\*: Assessing the correlation between serum uric acid levels and the severity of liver fibrosis in adult obese patients with NAFLD. 4- To identify potential mechanisms underlying the association\*: Exploring the potential mechanisms by which hyperuricemia may contribute to the development and progression of NAFLD and liver fibrosis in adult obese patients.

Imagery as Biomarker of Gout

The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Order to Evaluate the Need of Adjuvant Uric Acid Lowering Therapy

Background: Uricemia dramatically rises with the stage of chronic kidney disease (CKD) and correlates with its mortality. Hemodialysis (HD) being the most used treatment at the end stage kidney disease in Sohag governorate , we sought to evaluate its efficacy on the clearance of uric acid (UAc) when used alone and twice per week. Methods: A cross-sectional study of all consenting patients with CKD stage 5 recruited at random during hemodialysis sessions at hemodialysis unit in Sohag university hospital from July to December 2025. We collected socio-demographic data, relevant clinical information, hemodialysis related variables, and measured serum uric acid (SUA) levels before and after the dialysis to assess the uric acid clearance. A clearance between 65 and 80% and above 80% was considered as low and good efficacy of hemodialysis respectively

Effects of Fibres Combined With Probiotics on Uric Acid in an ex Vivo Fermentation Model

In this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples.

Metabolically Healthy Obesity Increases the Risks of MASLD and Hyperuricemia

Although metabolically healthy obesity (MHO) is often considered a relatively benign obesity, its association with the risk of metabolic dysfunction-associated steatotic liver disease (MASLD) and hyperuricemia remains unclear. This study examined the associations between MHO and other metabolic-obesity phenotypes with MASLD and hyperuricemia, and explored the mediating roles of metabolic indicators.This study included 11,712 and 13,846 participants from a health examination cohort at the First Affiliated Hospital of Ningbo University for MASLD and hyperuricemia analyses, respectively. Participants were classified into four metabolic-obesity phenotypes, with MHO defined as obesity without metabolic syndrome components. The outcomes were MASLD and hyperuricemia. Cox regression and mediation analyses were conducted to assess associations and mediating effects.

Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia

This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

This study aims at evaluating and comparing the protective outcomes of using Febuxostat versus Vitamin E in Hyperuricemia non-alcoholic steatohepatitis patients without cirrhosis. The intervention is 6-months duration and the study will assess the efficacy of either drug as fibrosis improvement (≥ 1 stage) with no worsening of NASH or NASH resolution with no worsening of fibrosis with the study considered successful if either 1ry end point is met. Also, assessment of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance and liver fibrosis will be done.

PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function

This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function.