Upper Hutt

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 evaluating BBT001 in a Phase 1 clinical trial involving healthy volunteers and adults with moderate to severe atopic dermatitis, a chronic skin condition. This randomized, blinded, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical effects of BBT001. The study includes both single ascending dose and multiple ascending dose parts to carefully test different dosing levels and effects.

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 evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

Researchers are evaluating BGB-45035 in a first-in-human study to understand its safety, tolerability, pharmacokinetics, and pharmacodynamics. The study includes healthy adults and adults with autoimmune skin diseases such as atopic dermatitis and prurigo nodularis. The study is a Phase 1 trial lasting up to 24 months and also includes a biomarker evaluation cohort. BGB-45035 and placebo are given orally as single or multiple doses at various levels. The study has several parts: Parts A-D involve up to 14 days of treatment in healthy participants; Part E involves up to 12 weeks of treatment in adults with autoimmune skin conditions; Part F includes up to 3 weeks of treatment for biomarker assessment. A safety follow-up occurs 30 days after the last dose. Participants will undergo clinical laboratory tests, vital sign checks, cardiac monitoring, and safety assessments from the first dose through follow-up. Researchers will track adverse events and monitor changes in lab values and heart function. The study measures safety and tolerability over varying durations depending on the study part, with close observation during and after treatment.

Researchers are evaluating the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-20118 in healthy adults and patients with moderate to severe plaque psoriasis. This Phase 1 trial is divided into two parts: a single ascending dose (SAD) study in healthy participants and a multiple ascending dose (MAD) study in patients with psoriasis. The study aims to understand how the drug behaves in the body and its effects after single and multiple doses. Part 1 (SAD) is a single-center, randomized, double-blind, placebo-controlled study involving five dose cohorts, each including 12 healthy participants receiving either HS-20118 or placebo orally. Part 2 (MAD) is a multi-center, randomized, double-blind, placebo-controlled study with six dose cohorts of patients with moderate to severe plaque psoriasis, each cohort also including 12 participants receiving multiple oral doses of HS-20118 or placebo. Both parts include blood sampling for pharmacokinetic, immunogenicity, and pharmacodynamic assessments along with safety evaluations. Participants will undergo various examinations including physical exams, vital signs monitoring, laboratory tests, electrocardiograms, and imaging where applicable. Safety is closely monitored by tracking adverse events and clinical abnormalities throughout the study periods (up to 36 days for SAD and 71 days for MAD). Blood samples will be collected for drug level measurements and immune response evaluation. The total duration and follow-up details are aligned with the dosing schedules in each study part.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). This Phase 1a/1b randomized, double-blind, placebo-controlled study includes multiple parts to assess single and multiple doses. The study may adjust the number of dosing groups in the first two parts based on ongoing results. In Part 1, healthy adults receive a single dose of TRB-061 or placebo, followed by 12 weeks of monitoring. In Part 2, healthy adults receive three doses every four weeks over eight weeks, with a 10-week follow-up. Part 3 involves participants with moderate-to-severe AD receiving four doses of TRB-061 or placebo over 12 weeks, followed by a follow-up period. After the main study, those on placebo may have the option to receive the active treatment. Participants will undergo regular safety assessments including medical history, physical exams, laboratory tests, and monitoring for adverse events from screening through follow-up. Researchers will measure the incidence of adverse events and serious adverse events across all parts of the study. The total participation duration varies by part but includes follow-up lasting up to 12 weeks after dosing to ensure safety and collect pharmacological data.

Researchers are evaluating the safety and effectiveness of OD-07656 in adults with moderately to severely active ulcerative colitis (UC). This Phase 2a study also aims to assess whether OD-07656 can improve the benefits of vedolizumab, a standard treatment, when given afterward. Participants must have a confirmed diagnosis of UC and have not responded adequately or tolerated previous UC therapies. Participants will receive OD-07656 as the experimental treatment. After completing treatment with OD-07656, some will receive vedolizumab to evaluate combined therapeutic effects. The study design includes an open-label and randomized approach to assess these treatments in a controlled manner. During the study, researchers will monitor changes in the 3-component modified Mayo Clinic Score to measure disease activity from the start to 12 weeks after treatment. They will also track any treatment-emergent adverse events and reasons for stopping treatment during this period. The trial involves regular assessments to ensure safety and evaluate the ongoing response to therapy over the 12-week timeframe.