Christchurch

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 molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are conducting a Phase I dose-escalation study to assess the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy adult volunteers. The study aims to understand how the drug behaves in the body and to monitor any side effects in participants who do not have underlying health conditions. Participants will receive either RO7875913 or a placebo according to a schedule detailed in the study protocol. The dose will be gradually increased to evaluate the drug's effects and safety at different levels. Both treatments are given as drugs, and the study focuses on healthy adults within a specific weight and body mass index range. During the study, researchers will closely monitor participants for any adverse events for up to approximately three months. Safety assessments, pharmacokinetic, and pharmacodynamic evaluations will be conducted throughout the study. Participants are expected to adhere to contraception requirements and will undergo various tests to ensure they meet health criteria before and during the trial.

Researchers are investigating the safety, tolerability, and how the body processes and responds to various doses of ARO-ALK7 in adults with obesity, including those with and without Type 2 Diabetes Mellitus (T2DM). This Phase 1/2a study includes a dose-escalation design and aims to understand the effects of single and multiple doses of ARO-ALK7 alone or combined with tirzepatide. Participants will receive ARO-ALK7 or a placebo through subcutaneous injections. The study consists of two parts: Part 1 evaluates single and multiple doses in adults with obesity without T2DM, and Part 2 assesses multiple doses in adults with obesity both with and without T2DM, either as monotherapy or combined with tirzepatide. The dosing will be escalated to understand safety and drug behavior. During the study, participants will be closely monitored for treatment-emergent adverse events up to Day 253, marking the end of the study. Researchers will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics through regular assessments. The total participation duration covers dosing and follow-up to assess outcomes and monitor safety throughout the study period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-INHBE in adults with obesity, with and without type 2 diabetes mellitus. This Phase 1/2a study includes dose escalation and investigates single and multiple doses of ARO-INHBE alone or combined with tirzepatide. The study aims to understand how the drug behaves in the body and its effects in these populations. The study involves subcutaneous injections of ARO-INHBE and placebo, with tirzepatide also administered as subcutaneous injections in combination groups. Part 1 focuses on adults with obesity receiving single or multiple doses of ARO-INHBE. Parts 2 and 3 assess multiple doses of ARO-INHBE alone or with tirzepatide in adults with obesity, both with and without type 2 diabetes. Placebo injections match the active treatment volume. Participants will undergo assessments including monitoring for treatment-emergent adverse events throughout the study, up to one year (365 days). They will be required to follow a stable diet and exercise routine and comply with all study procedures. Safety, tolerability, and drug behavior in the body will be evaluated, with close observation of any side effects or adverse events during the trial period.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the drug GRT7041 in healthy adult men and women who are not able to bear children. This early phase 1 trial aims to understand how the drug behaves in the body and its potential effects, focusing on healthy participants aged 18 to 60 years. The study includes both single and multiple dose assessments to gather comprehensive safety and biological data. The trial is divided into two parts: Part 1 involves single ascending doses (SAD) administered to up to five groups, including a special food effect group where participants receive a standardized breakfast with the drug. Part 2 involves multiple ascending doses (MAD) given once daily for 14 days to men only across three groups. Both parts include comparisons to placebo and examine interactions with another drug called Midazolam. Dosing is mainly done under fasting conditions, except for the food effect group. Participants will undergo a screening visit, stay at the study center for treatment and monitoring, and have a follow-up visit at the end of the trial. During the study, researchers will monitor for adverse events, serious adverse events, and perform health assessments like ECG, vital signs, laboratory tests, and physical exams. The trial duration ranges from about 6 to 8 weeks depending on the group, with a total treatment period up to 14 days for multiple dosing. Safety and tolerability are closely observed throughout the study.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are conducting a Phase 1 trial to compare the pharmacokinetics, immune response, safety, and tolerability of two drugs, Bmab3000 and Herceptin Hylecta, after a single subcutaneous dose. This study involves healthy male volunteers aged 18 to 65 years with specific weight and health criteria. The goal is to evaluate these two treatments to understand their behavior and safety in the body. Participants will be randomly assigned to receive either a single 600 mg subcutaneous injection of Bmab3000 or Herceptin Hylecta. The study includes two groups with 75 men each, stratified by body weight. The study period involves one screening visit, a 3-night inpatient stay for dosing and initial monitoring, and 16 scheduled outpatient visits for follow-up, lasting about four months in total. During the study, participants will undergo thorough assessments including medical history, physical exams, vital signs, ECGs, echocardiograms, and blood and urine tests. Safety monitoring will be continuous during the inpatient phase and regular during outpatient visits. Researchers will measure drug levels in the blood, immune responses, and monitor heart function and overall health throughout the study, with the final evaluations occurring on Day 91.

Researchers are conducting a Phase 1 clinical trial to study the safety, tolerability, and pharmacokinetics of LTG-001, a drug administered orally or intravenously, in healthy adult volunteers aged 18 to 55 years. The trial is randomized, double-blind, and placebo-controlled, involving both single ascending dose (SAD) and multiple ascending dose (MAD) stages. The goal is to understand how LTG-001 behaves in the body and how well it is tolerated when given in increasing doses. Participants will receive either LTG-001 or a placebo by mouth or through an intravenous route. The study includes periods where single doses and multiple doses are administered over up to 10 days for oral dosing and up to 14 days following intravenous dosing. This setup allows researchers to compare the effects of different dosing methods and to assess factors such as relative bioavailability and the impact of food on the drug's absorption. During the study, participants will undergo medical evaluations including physical exams, laboratory tests, and ECGs to monitor safety. Researchers will track drug levels in the body and watch for any side effects throughout the dosing and follow-up periods, which can last up to 35 days in total. The primary outcomes focus on safety, tolerability, and pharmacokinetic measurements from initial dose administration through study completion.

Researchers are evaluating the safety, tolerability, how the body processes, and effectiveness of TERN-701, a selective allosteric inhibitor targeting BCR-ABL1, in adults with chronic phase chronic myeloid leukemia (CP-CML) who have been previously treated. The study is divided into two parts: Part 1 focuses on dose escalation to find safe dosage levels, and Part 2 involves randomized dose expansion to further assess the chosen doses and includes a mutation cohort for participants with certain resistance mutations. Participants in both parts will take TERN-701 orally once daily in 28-day cycles. Part 1 involves sequential dose escalation cohorts, while Part 2 evaluates two recommended dose levels selected from Part 1. The mutation cohort (Part 2m) will assess a specific 500 mg dose in participants with particular resistance mutations. Scheduled visits occur frequently during the first treatment cycle and then regularly throughout the study to monitor treatment effects. During the study, participants will have regular visits for evaluations including safety checks and laboratory tests. Researchers will measure dose-limiting toxicities, adverse events, hematologic response, molecular response, and changes in BCR-ABL1 transcript levels up to three years. The trial plans to enroll about 180 participants, with up to 80 in Part 1, about 80 in Part 2, and around 20 in the mutation cohort. All participants will receive the active treatment throughout the study duration.