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Found 11 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of IG3018 tablets in adults aged 18 to 75 years with hyperuricemia, with or without chronic kidney disease (CKD). This Phase I/II clinical study includes participants both without CKD and those with advanced predialysis CKD (Stages 3a, 3b, and 4). The study aims to understand how IG3018 affects serum uric acid levels and overall safety in these groups. The study has two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation trial involving hyperuricemia subjects without CKD. Participants receive IG3018 tablets starting at 0.25 g, with planned dose increases to 0.5 g and then 1.0 g. Part 2 is an open-label proof-of-concept study including subjects with advanced CKD who receive either 0.5 g or 1.0 g of IG3018 twice daily. The IG3018 and matching placebo are given orally. Participants will be monitored from baseline through up to 46 days for safety and tolerability. Researchers will measure changes in serum uric acid levels, aiming for normalization (≤ 0.36 mmol/L) at 4 weeks. Assessments include laboratory tests, physical exams, and monitoring for adverse effects. Participants must comply with study procedures and provide informed consent throughout the study period.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of NNC0487-0111 for people with excess body weight and knee osteoarthritis. This Phase 3 study compares NNC0487-0111 to a placebo, a treatment with no active medicine, to see if it helps reduce weight and knee pain. Participants have knee osteoarthritis diagnosed by specific clinical and radiographic criteria and experience ongoing knee pain. Participants receive weekly injections under the skin using a pre-filled pen injector. The injections, either NNC0487-0111 or placebo, are given in the thigh, abdomen, or upper arm. The study treatments include two dose levels of NNC0487-0111. Treatment assignment is randomized and blinded, meaning participants receive either the medicine or placebo by chance, not by choice. During the study, participants will be monitored for changes in body weight and knee pain using a standardized pain questionnaire over about 80 weeks. They will follow specific instructions about pain medication before assessments. Researchers will track treatment effects, safety, and any side effects throughout the study period.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of eloralintide, a drug given by injection, in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 study includes both a main phase and an extension phase to understand the drug's impact on body weight and overall health in this population. The study aims to compare eloralintide with a placebo to see how well it works in reducing weight. Participants will receive either eloralintide or a placebo, both administered under the skin once a week. The main study phase will last about 75 weeks, during which participants will be regularly monitored. Those participants who have prediabetes will have the option to continue into an extension phase lasting an additional 2 years to further assess long-term effects. During the study, participants will have their body weight measured at the start and throughout the trial, with the primary outcome being the percent change in body weight at week 64 compared to baseline. Researchers will also monitor safety and any side effects. Participants will be asked about their weight history and health conditions, and they must maintain stable body weight before joining. The total involvement time for most participants will be about 75 weeks, with longer follow-up for some.
Actively Recruiting
Researchers are investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.
Actively Recruiting
Researchers are evaluating the effects of macupatide and eloralintide, alone or combined, on weight loss in adults who are overweight or have obesity along with type 2 diabetes. This Phase 2 study aims to understand how these treatments might help reduce body weight in this population. The study is designed as a parallel-group, double-blind, placebo-controlled trial to ensure unbiased results. Participants will receive either macupatide, eloralintide, both drugs together, or matching placebos. All treatments are administered by subcutaneous injection. The study treatment period lasts approximately 48 weeks, during which the effects of the drugs on weight and diabetes control will be assessed. During the study, participants will be monitored for changes in body weight from the start of the study to week 32 as the primary outcome. Researchers will also evaluate safety and other health measures throughout the nearly year-long participation. The study includes regular assessments to track the effects of treatment and to ensure participant health and safety.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the safety and immune response of two new vaccine formulations against Group A Streptococcus pyogenes (Strep A) in healthy young adults aged 18 to 25 years. This Phase 1 study tests vaccines with two different adjuvants, Aluminum Hydroxide (Alum) and AS37, in low, medium, and high doses. The goal is to assess immediate reactions and determine the vaccines' ability to stimulate the immune system as they are tested in humans for the first time. Participants will receive three doses of the vaccine or placebo, administered intramuscularly on Days 1, 31, and 121. The study includes groups receiving low, medium, and high doses of each vaccine formulation, plus a placebo group. Each dose is given by injection into the muscle to evaluate safety and immune response across different strengths and vaccine types. During the study, participants will be monitored for side effects and immune reactions. Researchers will track any local or systemic reactions up to seven days after each dose, along with any adverse events occurring within 30 days. Laboratory tests will be done a week after each dose to check for abnormalities. Safety assessments for serious adverse events and adverse events leading to withdrawal will continue through Day 301. Participants will complete electronic diaries and attend follow-up visits throughout the study period to support thorough safety and immune response evaluation.
Actively Recruiting
Researchers are conducting a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 3 study to assess the effectiveness, safety, and tolerability of a single intra-articular injection of PTP-001 (MOTYS) in adults aged 40 to 80 years with knee osteoarthritis. The study focuses on participants with mild to moderate radiographic knee OA and symptomatic knee pain, aiming to compare PTP-001 against a placebo over a 52-week period. Participants will be randomly assigned in equal numbers to receive either a single dose of PTP-001 or a placebo saline injection into the target knee on Day 1. The study includes a screening period up to 28 days before treatment, a one-day treatment phase, and a 12-month follow-up phase. A total of at least 260 participants are planned, with 130 in each treatment group. During the study, participants will undergo evaluations to measure improvements in knee function and pain at 6 months. Researchers will monitor symptoms using pain scales and collect safety data throughout the year. Participants are expected to adhere to study visit schedules, use acetaminophen as needed for knee pain, and avoid other unauthorized medications during the trial.
Actively Recruiting
Researchers are conducting a Phase 2, randomized, double-blind, international multicenter study to assess the safety and effectiveness of ABP-745 in adults experiencing acute gout flares. The study compares ABP-745 with standard colchicine treatment and placebo to evaluate their impact on reducing pain and swelling. The main focus is to measure pain relief after treatment using a visual analog scale. Participants are assigned to one of four groups receiving either two different doses of ABP-745 with colchicine placebo, colchicine with ABP-745 placebo, or double placebo tablets. Treatments are given orally. The study monitors pain changes 24 hours after the first dose. The trial includes adults aged 18 to 70 with a history of gout flares and evaluates responses shortly after flare onset. During the study, participants will undergo assessments including pain scoring to track changes in joint pain. Researchers will monitor safety and treatment effects throughout the treatment period. The total participation timeline includes screening and treatment phases, with attention to medication stability and lifestyle consistency. Pain score changes 24 hours post-treatment serve as the primary outcome measure for evaluating treatment efficacy.
Actively Recruiting
Healthy Volunteer
Researchers are conducting a Phase 1/2 randomized, observer-blinded, dose-escalation trial to evaluate the safety, tolerability, and immune response of an investigational herpes zoster vaccine called Z-1018 compared to the approved Shingrix vaccine. The study involves healthy adults aged 50 years and older, aiming to better understand how these vaccines perform in preventing shingles and related complications. In Part 1 of the trial, about 440 participants aged 50 to 69 years will be randomly assigned to one of ten groups receiving different doses of Z-1018 or to the Shingrix group. Part 2 will enroll approximately 324 participants aged 70 years or older to receive either the selected Z-1018 dose from Part 1 or Shingrix in a 1:1 ratio. Participants receive two vaccine doses, and Part 2 includes extended follow-up for four years after the initial 12-month post-vaccination period to assess long-term immune protection and incidence of shingles and postherpetic neuralgia. Participants will be monitored for local and systemic reactions up to seven days after each dose and adverse events for 28 days post-injection. Serious and medically attended adverse events will be tracked for up to 12 months after the last dose. Immune responses will be measured four weeks after the second dose by vaccine response and antibody levels. Study visits include medical evaluations, laboratory tests, and adherence assessments throughout the trial duration.
Actively Recruiting
Healthy Volunteer
The trial investigates PRA-216, a biologic drug, in both healthy volunteers and participants with mild to moderate asthma. It is a Phase 1/2a randomized, double-blind, placebo-controlled study designed to assess safety, tolerability, pharmacokinetics, immunogenicity, and efficacy. The study includes single and multiple ascending dose parts in healthy individuals and a Phase 2a portion to evaluate PRA-216 in asthma patients based on Phase 1 findings. Phase 1 consists of two parts: Part 1 (single ascending dose) administers one dose of PRA-216 or placebo intravenously or subcutaneously to healthy volunteers, while Part 2 (multiple ascending dose) gives repeat subcutaneous doses to healthy volunteers. Phase 2a enrolls participants with mild to moderate asthma who receive PRA-216 or placebo to assess the drug's effect on asthma symptoms and exhaled nitric oxide levels. Dosages and schedules in Phase 2a are informed by Phase 1 safety and pharmacokinetic data. Participants attend multiple visits for dosing and data collection throughout the study periods, including up to Study Day 169 for Phase 1 and Day 57 for Phase 2a. Researchers monitor serious adverse events, pharmacokinetics, immunogenicity, and asthma-related outcomes such as exhaled nitric oxide. Safety, tolerability, and effectiveness are evaluated, with participants providing informed consent and complying with study requirements across the study timeline.
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