Camberwell

Researchers are investigating the safety, tolerability, pharmacokinetics, and effectiveness of the drug IG3018 in people with high uric acid levels hyperuricemia, including those with and without chronic kidney disease CKD. This phase III clinical trial aims to better understand how IG3018 works in these groups and to explore appropriate dosing. The study is sponsored by Intelligem Therapeutics Australia Pty Ltd and includes participants aged 18 to 75 years. The trial has two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation study in participants without CKD, testing increasing doses of IG3018 tablets 0.25 g, 0.5 g, and 1.0 g. Each dose cohort receives a single dose followed by four weeks of twice-daily maintenance dosing. Part 2 is an open-label study in participants with advanced predialysis CKD Stages 3a, 3b, and 4, who receive either 0.5 g or 1.0 g of IG3018 twice daily for four weeks. Participants will attend study visits for blood and urine sample collection to analyze drug levels and kidney function. Safety and efficacy will be assessed through laboratory tests, gout attack monitoring, and uric acid measurements over about 46 days. The study tracks changes in serum uric acid levels, kidney function markers, and drug pharmacokinetics. Participants must provide consent and follow study procedures throughout the treatment and monitoring periods.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating the safety and effectiveness of a new medicine called CagriSema in helping adults living with obesity, with or without type 2 diabetes, to lose weight. This phase 3 clinical study compares two different weekly doses of CagriSema against an existing medicine, semaglutide. The study aims to understand how well these treatments support weight loss over a long period. Participants in this study will be randomly assigned to receive one of three treatments CagriSema at dose level 1, CagriSema at dose level 2, or semaglutide. Each treatment is given by weekly injection under the skin for 72 weeks. The study lasts about 83 weeks, covering treatment and follow-up periods to observe effects and safety. During the study, participants will have regular assessments to monitor body weight, body mass index BMI, waist size, cholesterol levels, blood sugar control HbA1c, and quality of life. Researchers will track changes from the start of treatment to the end of 72 weeks, including weight loss milestones and health measurements. Safety will also be closely monitored through reports of any adverse events until the study ends.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are studying the safety, side effects, and immune responses of different versions of investigational vaccines targeting Respiratory Syncytial Virus RSV and Human Metapneumovirus hMPV in younger and older adults. The study is a Phase 12 clinical trial evaluating these vaccines in adults aged 18 to 49 years and 60 to 80 years. The goal is to understand how the vaccines perform in these age groups to help prevent RSV and hMPV infections. Participants receive a single intramuscular dose of one of several investigational RSVhMPV combination vaccines or hMPV vaccines at the start of the study. There are multiple vaccine formulations with varying doses for both younger and older adults. Control vaccines and placebos are also administered for comparison. The vaccines are given according to a single-dose schedule in two phases Phase 1 and Phase 2. Throughout the study, participants are monitored for local and systemic side effects from Day 1 to Day 7, and for any other adverse events up to 12 months or longer depending on their group. Blood tests measure immune responses to the vaccines at several time points including before vaccination and up to one month after. Researchers also evaluate serious side effects and immune-related disorders for up to 24 months in selected groups. Participants complete electronic diaries and attend follow-up visits to help track safety and immune responses over time.

Researchers are studying weight reduction in adults living with obesity or overweight who also have type 2 diabetes. The study evaluates two drugs, macupatide and eloralintide, given alone or together, to understand their effects on body weight. This Phase 2 trial is designed to assess these treatments in a controlled setting with participants randomly assigned to different groups. Participants will receive one of four treatments macupatide with an eloralintide placebo, eloralintide with a macupatide placebo, both macupatide and eloralintide together, or double placebo. All drugs are administered by subcutaneous injection. The main treatment period lasts about 32 weeks, during which the effects on body weight and diabetes-related measures are monitored. Throughout the study, participants will have evaluations including body weight, hemoglobin A1c levels, body mass index, and fasting glucose at the start and at week 32. The study involves a total participation duration of about 48 weeks, allowing for treatment, follow-up, and monitoring. The sponsor is Eli Lilly and Company, and the trial uses double-blind, randomized design to compare treatments fairly.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating OLX72021, a drug being studied for safety, tolerability, and how it behaves in the body in medically healthy men aged 18 to 59 years with mild to moderate androgenetic alopecia. This Phase 1b2a double-blind, randomized, placebo-controlled trial aims to assess the effects of multiple doses of OLX72021 compared to placebo. The study will be conducted in two phases, with Phase 1b focusing on dose escalation and Phase 2a on expanded dosing groups. During Phase 1b, participants will receive three intradermal injections of OLX72021 or placebo, spaced 28 days apart, in sequential dose level cohorts involving 12 participants each. In Phase 2a, four groupsincluding one placebo group and three OLX72021 dose groupswill receive six intradermal treatments, also 28 days apart. The study evaluates up to two dose levels, with approximately 24 participants in Phase 1b and about 134 participants in Phase 2a. Participants will attend scheduled visits over the study period for assessments including safety monitoring, local injection site tolerability, and hair count measurements in target areas up to 24 weeks. Blood samples will be collected for pharmacokinetic analysis. The study will track adverse events and serious adverse events, as well as changes in hair count, to understand the drugs safety and effects. The total duration includes follow-ups to day 169 in Phase 2a.

This research aims to evaluate the safety and immune response of two new formulations of the GSK 4-component Strep A vaccine in healthy young adults aged 18 to 25. The study will assess low, medium, and high doses of the vaccine combined with either an Alum or AS37 adjuvant. It is a phase 1 clinical trial to monitor immediate reactions and immune responses in participants receiving the vaccine for the first time. Participants are randomly assigned to one of seven groups receiving three doses of either low, medium, or high doses of the Strep A vaccine with Alum or AS37 adjuvant, or an Alum placebo. Doses are administered intramuscularly on Day 1, Day 31, and Day 121 in a sequential study design. The trial compares multiple doses and formulations to assess safety and immunogenicity. Throughout the study, participants will be monitored for solicited and unsolicited adverse events for up to 301 days. Laboratory tests, including blood samples, will be collected to assess immune responses at various time points before and after vaccinations. Participants will complete electronic diaries and attend follow-up visits to report any reactions and provide samples for detailed immunological analysis.