Berlin

Researchers are evaluating the safety and effectiveness of a new medication called CX11 in adults with type 2 diabetes who have not achieved good blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This Phase 2 study is conducted at multiple medical centers and uses a randomized, double-blind, placebo-controlled design to compare different doses of CX11 against placebo over a 24-week treatment period. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 tablets or matching placebo tablets taken orally once daily. The treatment phase lasts 24 weeks, followed by a 2-week safety follow-up period where researchers will monitor participants for any side effects or health changes after stopping the study medication. Throughout the study, participants will undergo assessments including blood tests to measure changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 24. Other evaluations will monitor safety and health status. The total participation time is approximately 26 weeks, including treatment and follow-up. Researchers will also track adherence to medication and lifestyle instructions during this time.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

Researchers are evaluating the Intelligent Fingerprinting Drug Screening System by comparing its test results for opiates in fingerprint sweat to those obtained from a validated laboratory technique called LC-MS/MS. The study involves healthy adult males and non-pregnant females aged 18 to 65 to assess the accuracy, sensitivity, and specificity of this drug screening system. The study also aims to evaluate how easy the system is to use and how consistent the results are when operated by intended users. The study involves two groups of participants: "operators," who are trained adults that will use the drug screening system but will not receive any drug, and "donors," healthy adults who will provide fingerprint sweat specimens. Donors are randomized to receive either 0, 30, or 60 mg of codeine sulfate by tablet before providing samples. Operators will be trained using guides and must pass a training exam before performing tests. The screening system uses a qualitative lateral-flow immunoassay cartridge, and samples are also analyzed using laboratory techniques. Participants will be involved in providing fingerprint sweat samples and undergoing drug administration (for donors). Researchers will monitor test results from both the screening system and laboratory analysis, focusing on comparing accuracy and usability. Safety assessments include medical history reviews, vital signs, and pregnancy testing for females. The study involves screening within 30 days before dosing and includes monitoring participants during and after drug administration to ensure safety and collect data for method comparison within a timeframe of 30 minutes to 3 hours after dosing.

Researchers are studying whether adding ABX-002 to an existing antidepressant can improve depression symptoms in adults aged 18 to 65 with moderate to severe major depressive disorder who have not adequately responded to their current treatment. This Phase 2, double-blind, placebo-controlled study randomly assigns participants to receive either ABX-002 or a placebo alongside their antidepressant medication. Participants must have a current major depressive episode lasting more than 6 weeks and up to 18 months, and meet specific depression and anxiety rating scores to qualify. Participants will take ABX-002 or placebo oral solution once daily on an empty stomach, followed by water. The study includes a screening period of about 35 days, followed by a 42-day treatment period, a 2-week safety follow-up after dosing, and a 6-month targeted safety follow-up. Throughout these phases, participants continue their stable antidepressant treatment without changes. During the study, participants undergo assessments including depression rating scales to measure changes in symptoms. Researchers monitor safety through follow-up visits after treatment ends. The main outcome measured is the change in depression severity from the start to 6 weeks after treatment begins. Total participation spans several months, including screening, treatment, and extended safety monitoring.

This research aims to evaluate the long-term safety, tolerability, and effectiveness of NMRA-335140 in adults with major depressive disorder (MDD). It involves participants who completed earlier Phase 3 studies of NMRA-335140 for MDD and met specific eligibility and consent requirements. The study provides an opportunity to extend treatment and monitor outcomes over a longer period. Participants will receive NMRA-335140 at a dose of 80 mg taken orally once daily for a 52-week treatment period. This open-label extension allows continued assessment beyond the initial parent studies, focusing on sustained safety and effectiveness of the medication. Throughout the 52 weeks, researchers will monitor participants for treatment emergent adverse events and use validated clinical scales to assess safety and tolerability. The study's total duration for participants is up to 54 weeks, including safety assessments. Data collected will help understand the long-term effects of NMRA-335140 in managing MDD.