Pula

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults who have excess body weight and type 2 diabetes. This Phase 3 clinical trial compares NNC0487-0111 with a placebo to see how well it helps participants lose weight. The study focuses on adults diagnosed with type 2 diabetes at least 180 days before screening, who have a specific range of blood sugar levels (HbA1c between 7-10%). Participants receive treatments as weekly injections under the skin using a pre-filled pen injector (PDS290) applied to the thigh, abdomen, or upper arm. They are randomly assigned to receive either NNC0487-0111 or a placebo that looks like the active treatment but contains no medicine. The study treatments are given once a week throughout the trial. During the study, participants are monitored for changes in their body weight from the start of the trial up to week 84. Researchers also assess safety and other health measures. Participants continue their usual treatment with lifestyle changes or certain oral diabetes medications that have been stable before joining. The trial follows them closely to evaluate how the treatment affects their weight and diabetes control over time.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.