Morayfield

Researchers are evaluating ARO-ALK7, a drug given by injection, in adult participants with obesity, both with and without Type 2 Diabetes Mellitus T2DM. This Phase 12a study aims to understand the safety, tolerability, how the body processes the drug, and how the drug affects the body. The study is divided into two parts Part 1 focuses on adults with obesity without T2DM, and Part 2 includes adults with obesity both with and without T2DM, testing ARO-ALK7 alone or combined with tirzepatide. Participants receive either single or multiple doses of ARO-ALK7 or matching placebo injections. In Part 2, some participants also receive weekly tirzepatide starting from Day 15 through Day 253. The doses of ARO-ALK7 are escalated to explore different levels of the drug. The study compares ARO-ALK7 alone, placebo, ARO-ALK7 combined with tirzepatide, and placebo combined with tirzepatide to assess their effects. During the study, participants are monitored for treatment-emergent adverse events until Day 253. Researchers collect detailed information on how the drug moves and acts in the body, especially during Part 1. Participants will have scheduled visits to receive treatments and undergo safety and effectiveness assessments. The total study duration covers up to about 8 and a half months, including dosing and follow-up, to fully evaluate the drugs impact and safety profile.

Researchers are evaluating the use of PTP-001 MOTYS, an allogeneic human placental tissue particulate, for treating knee osteoarthritis OA. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and effectiveness of a single injection of PTP-001 compared to placebo over a 52-week period in adults aged 40 to 80 with symptomatic and radiographically confirmed knee OA. Participants will be randomly assigned to receive one injection into the target knee of either 200 mg PTP-001 or 4 mL of placebo saline solution. The study includes a screening period lasting up to 28 days before treatment, a one-day treatment phase when the injection occurs, and a follow-up phase of 12 months to monitor outcomes and safety. Approximately 260 participants will be enrolled, with 130 in each treatment group. During the study, participants will undergo assessments at multiple time points, including evaluations of knee pain and function using standardized scales such as WOMAC and patient global assessments. The main outcomes focus on the proportion of participants showing strict improvement in knee pain and function at 6 months, with additional measurements at 9 and 12 months. Safety and tolerability will also be monitored throughout the follow-up period.

Researchers are evaluating the safety of IGT-303 in healthy volunteers and people with Chronic Kidney Disease CKD, particularly those with stage 2-3b CKD due to Type 2 diabetic nephropathy. This clinical trial aims to determine if IGT-303 is safe when given as a single dose or multiple doses under the skin subcutaneous or into a vein intravenous. The study compares IGT-303 to a placebo to assess safety and tolerability. Participants will be randomly assigned to receive either IGT-303 or a placebo, with treatments given as a single ascending dose in six groups Part A or multiple ascending doses in three groups Part B. The placebo used is normal saline. The study includes both single and multiple dose phases, with monitoring over time. During the study, participants will be assessed for adverse events and treatment-emergent side effects from screening until day 84. Researchers will also measure how the body processes IGT-303 through pharmacokinetic tests during this period. Participants may have overnight stays at the research site and will be followed closely to monitor safety and treatment effects throughout the study duration.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are studying GRWD0715, an oral drug that selectively inhibits the Endoplasmic Reticulum Aminopeptidase 1 ERAP1 enzyme, as a potential treatment for axial spondyloarthritis axSpA. AxSpA is a long-term inflammatory condition mainly affecting the sacroiliac joints and spine. The study explores whether blocking ERAP1 can reduce the immune systems attack on these joints by preventing the creation of inflammatory self-peptides. The trial has four parts involving both healthy volunteers and people with axSpA. Part A tests single doses of GRWD0715 in healthy volunteers, while Parts B and C involve participants with axSpA receiving multiple doses over 4 weeks and 12 weeks respectively. Part D compares GRWD0715 with a placebo over 12 weeks to assess efficacy. Some participants may roll over between parts without washout periods, continuing treatment based on their previous dose. Participants will undergo various assessments including monitoring for dose-limiting events, treatment-related and emergent adverse events, and MRI scans of the sacroiliac joints and spine to measure inflammation. Blood samples will be taken to study drug levels. The study evaluates safety, tolerability, and preliminary effectiveness over several weeks, with follow-up visits extending up to 12 weeks depending on the study part. Overall participation may last several months depending on enrollment in different parts of the trial.

Researchers are evaluating the effectiveness and safety of ribupatide KAI-9531 given as a once-weekly subcutaneous injection compared to semaglutide and placebo for people living with obesity who do not have diabetes. This Phase 3, randomized, partially-blinded study aims to show that ribupatide is superior in reducing body weight. Participants included have a body mass index BMI of 35 kgm or higher and a history of unsuccessful weight loss attempts through diet and exercise in the past 6 months. Participants will be randomly assigned to one of four groups two different doses of ribupatide once weekly, semaglutide once weekly, or a placebo injection once weekly. The study treatment is administered by subcutaneous injection, and the treatment period lasts for 76 weeks. The study compares the percentage change in body weight among these groups and also monitors several other health measures related to weight, metabolism, quality of life, and safety. During the study, participants will have regular visits for assessments including body weight, waist circumference, blood pressure, cholesterol levels, and questionnaires about eating behaviors and quality of life. Researchers will also monitor for any adverse events and test for antibodies against the study drugs throughout the 80-week period. The total participation duration may extend up to 80 weeks, including safety follow-up after the treatment period ends.

Researchers are studying the effects of ribupatide KAI-9531, given as a weekly subcutaneous injection, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if ribupatide is better than a placebo in reducing body weight and lowering hemoglobin A1c HbA1c, a key marker of blood sugar control. This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating safety and efficacy. Participants will be randomly assigned to receive one of four doses of ribupatide or a matching placebo once weekly. The study compares the effects of these different doses over time, focusing on changes in weight and HbA1c levels at week 76. The intervention involves subcutaneous injections administered once a week, with multiple doses tested to evaluate their impact relative to placebo. During the study, participants will be monitored regularly to measure changes in body weight, HbA1c, waist circumference, blood pressure, cholesterol levels, glucose, insulin, and quality of life related to weight. Safety assessments include tracking adverse events and immune responses to the drug. Blood samples will be collected to measure ribupatide concentrations. The study lasts up to 76 weeks, with ongoing monitoring for treatment effects and safety throughout this period.

Researchers are evaluating the preliminary efficacy, safety, and population pharmacokinetics PopPK of ABP-745 in adults aged 18 to 75 years who have atherosclerotic cardiovascular disease ASCVD. This randomized, double-blind, placebo-controlled Phase II study aims to compare the ability of ABP-745 to reduce atherosclerotic plaque against a placebo. The primary measurement of efficacy will be the change in percent atheroma volume PAV after 52 weeks of treatment. Participants will be randomly assigned to one of four groups placebo or one of three different doses of ABP-745 tablets taken orally once daily. Throughout the study, existing lipid-lowering maintenance medications will remain unchanged. The study includes a 52-week treatment period, after which the primary outcome will be assessed. Safety and tolerability will also be monitored up to 14 days after the last dose. During the study, participants will continue their current oral lipid-lowering therapy and attend regular visits for assessments including physical exams, vital signs, laboratory tests, and ECGs. Researchers will measure changes in atherosclerotic plaque volume and monitor for adverse events. The total duration of participation includes the 52-week treatment period plus safety follow-up, with detailed monitoring to evaluate the impact and safety of ABP-745 in this population.

Researchers are evaluating the safety, immune response, and effectiveness of different doses of a Chlamydia messenger RNA mRNA vaccine in adults aged 18 to 29 years. The study includes three initial Sentinel Cohorts to carefully assess safety at low, medium, and high dose levels before expanding to a Main Cohort. The overall goal is to understand how well this vaccine candidate works and its safety profile in young adults. Participants will receive three injections of either a low, medium, or high dose of the Chlamydia mRNA vaccine or a placebo. The injections are given intramuscularly. The study is randomized and placebo-controlled, with multiple groups based on whether participants have prior exposure to Chlamydia trachomatis. The study is designed with stepwise safety assessments in the Sentinel Cohorts followed by evaluation in a larger Main Cohort. During the study, participants will be monitored for immediate reactions up to 30 minutes after vaccination and for side effects up to 12 months following the last injection. Immune responses will be measured through blood tests before and after each vaccine dose. Participants will be followed for about 18 months from the start, including safety monitoring, laboratory tests, and evaluation of immune responses to the vaccine and placebo injections.

Researchers are studying the safety and effectiveness of HB-1 compared to a placebo in adults aged 18 to 65 years who have Post-Traumatic Stress Disorder PTSD. This is a phase 2, multi-center, double-blind, placebo-controlled trial involving approximately 200 to 500 adults diagnosed with PTSD who do not have severe neuropsychiatric or medical conditions. The study takes place at multiple sites in Australia and the United States. Participants will receive either HB-1 or a placebo tablet once daily for 12 weeks. HB-1 doses start at 64192 mg of telmisartanverapamil extended release and may be increased to 86258 mg based on treatment response and tolerance assessed at weeks 4 and 8. Those showing a 50% or greater reduction in PTSD symptoms remain on the same dose, while others without severe side effects may have their dose increased. A safety follow-up visit occurs one week after the last dose to monitor any adverse effects. During the study, participants will undergo assessments at baseline, week 4, week 8, and week 12, including symptom rating scales such as CAPS-5 and other PTSD-related questionnaires. Safety evaluations include monitoring for adverse events, vital signs, ECGs, and laboratory tests. The studys main goal is to measure changes in clinician-rated PTSD symptoms, along with secondary measures of stress, symptoms, and disability. Participation lasts for approximately 13 weeks including treatment and safety follow-up.