Berlin

Researchers are evaluating a new medication called CX11 for adults with type 2 diabetes who have not achieved adequate 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 randomized, double-blind, and placebo-controlled, aiming to determine the safety and effectiveness of different doses of CX11 in comparison to placebo. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 40 mg, 80 mg, 120 mg, 160 mg, or 200 mg or a matching placebo. The medication is taken orally once daily for 24 weeks, followed by a 2-week safety follow-up period. The study is conducted across multiple medical centers and neither participants nor staff will know the group assignments during the trial. Throughout the study, participants will undergo regular assessments including blood tests to measure changes in HbA1c a marker of blood sugar control, fasting plasma glucose, body weight, and blood pressure. Continuous glucose monitoring will track time spent in the target glucose range. Safety is monitored by recording adverse events and measuring plasma drug levels at specified intervals. The total participation period is approximately 26 weeks.

This trial is for patients with hypertension who have completed previous QCZ484 studies. It aims to gather more information on the long-term safety and effectiveness of QCZ484, a treatment given to lower high blood pressure. The study is an extension phase to build on prior research results for hypertensive patients who successfully finished earlier treatment periods. Participants in this open-label extension study will receive QCZ484 by subcutaneous injection every six months. This single-group, multicenter study offers enrollment to patients at the month 12 visit of their parent study, provided they meet eligibility and have completed their prior treatment safely. The treatment continues to be monitored for up to 66 months to assess ongoing effects and tolerability. During the study, participants will have regular assessments including ambulatory and office blood pressure measurements at baseline and throughout the extension period. Safety will be closely monitored by tracking any adverse events up to 66 months. The study collects data on blood pressure changes and side effects to understand how well QCZ484 works and how safe it remains over the long term. Participation involves scheduled visits aligned with the injection schedule and ongoing health evaluations.

Researchers are evaluating the Intelligent Fingerprinting Drug Screening System to compare its accuracy and usability against a standard laboratory test for detecting opiates in fingerprint sweat. The study involves healthy adult males and non-pregnant females aged 18 to 65. It aims to assess the sensitivity, specificity, and accuracy of this new drug screening method as well as how easy and consistent it is to use. The study includes two groups operators, who are trained adults using the screening system without drug administration, and donors, who are healthy adults randomized to receive either 0 mg, 30 mg, or 60 mg of codeine sulfate. The operators will be trained using guides and a training exam before conducting tests. Donors provide fingerprint sweat samples after dosing for analysis by both the new screening system and a laboratory method. Participants will provide fingerprint sweat specimens which will be tested and compared with laboratory analysis using liquid chromatographytandem mass spectrometry. The study will measure method comparison outcomes within 30 minutes to 3 hours and assess usability over 72 hours. Participants will be monitored for health status and follow-up assessments to measure the reproducibility and accuracy of the screening system throughout the study period.

Researchers are evaluating whether adding ABX-002 to an existing antidepressant treatment can improve depression symptoms in adults with moderate to severe major depressive disorder who have not adequately responded to their current antidepressant. This Phase 2, double-blind, placebo-controlled study aims to compare ABX-002 against a placebo alongside stable doses of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors SSRISNRI. The study is sponsored by Autobahn Therapeutics, Inc. Participants will be randomly assigned to one of two groups one receiving ABX-002 oral solution and the other receiving a placebo, both taken as a 1-mL oral solution on an empty stomach each morning followed by water. All participants will continue their stable SSRI or SNRI antidepressant dose throughout the study. The study includes a screening period of about 35 days, a 42-day treatment period, a 2-week safety follow-up after dosing, and an additional 6-month targeted safety follow-up. During the study, participants will undergo assessments including the 17-item Hamilton Rating Scale for Depression HAMD-17 to measure changes in depression symptoms, as well as other scales like the Clinical Global Impression of Severity and Sheehan Disability Scale. Safety and tolerability will be monitored through adverse event reporting. The total participation time spans the screening through the extended safety follow-ups, with various evaluations conducted at specified intervals to track treatment effects and safety.