Camberwell

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

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.

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.

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.

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.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are studying OLX72021 in medically healthy men aged 18 to 59 with mild to moderate androgenetic alopecia. This Phase 1b/2a, double-blind, randomized, placebo-controlled trial aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of OLX72021 at up to two dose levels. The study focuses on how the drug affects hair growth and assesses adverse events during treatment. The study consists of two phases. In Phase 1b, sequential dose levels of OLX72021 will be tested in small groups, with participants receiving either the drug or placebo. Phase 2a will involve larger groups receiving multiple doses of OLX72021 or placebo concurrently. Dosing includes low, mid, and high levels of OLX72021, with placebo controls for comparison. Participants will attend multiple visits for injections, assessments, and blood draws. Researchers will monitor safety through adverse event tracking and local injection site tolerability up to Day 85. Hair growth will be measured by counting non-vellus hair in target areas at 24 weeks (Day 169). Overall, the study will evaluate both short-term safety and longer-term effects on hair growth.

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.

Researchers are studying the effectiveness and safety of KAI-9531, a drug given as a once-weekly subcutaneous injection, in adults living with obesity who do not have diabetes. The study aims to show that KAI-9531 leads to greater weight loss compared to semaglutide, another injection given weekly, and a placebo. This is a Phase 3 randomized, partially-blinded trial that compares these treatments in people with a body mass index (BMI) of 35 kg/m² or higher who have tried and failed to lose weight through diet and exercise within the last six months. Participants will be assigned to receive either KAI-9531, semaglutide, or a placebo, all administered by subcutaneous injection once a week. The study will monitor changes in body weight over a period of 76 weeks to assess which treatment is more effective. The trial design includes active and placebo-controlled groups to carefully evaluate the impact of KAI-9531 on weight management. During the study, participants will undergo assessments to measure their body weight and other health parameters at baseline and throughout the 76-week period. The main outcome being measured is the percent change in body weight from the start of the study to week 76. Safety and tolerability of the treatments will also be monitored. Participants will be followed closely to ensure adherence and to track any side effects or changes in health status throughout the study duration.

Researchers are studying the effects of a drug called KAI-9531, given as a subcutaneous injection once a week, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if KAI-9531 is better than a placebo at reducing body weight and lowering hemoglobin A1c (HbA1c), a measure of blood sugar control, over a 76-week period. This Phase 3, randomized, double-blind, placebo-controlled trial focuses on those who have tried and struggled to lose weight through diet and exercise. Participants receive either KAI-9531 or a placebo through weekly injections under the skin. The study compares doses 3 and 4 of KAI-9531 against placebo to evaluate changes in body weight and HbA1c from the start of the study to week 76. The treatment is monitored closely throughout the trial to assess effectiveness and safety. During the study, participants will have their body weight and HbA1c measured at baseline and again at week 76 to observe changes. Researchers will also monitor safety and any side effects. The overall participation includes regular follow-ups and assessments to track progress and health status over the study duration.