Safety and Effects of CX11 Tablets in Women Aged 18 to 55 with Obesity or Overweight and Related Health Conditions

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of CX11 tablets in women aged 18 to 55 years who have obesity or are overweight with related health conditions. This Phase 1b study is multi-center, randomized, placebo-controlled, and double-blinded within cohorts, aiming to explore different doses of CX11 tablets. Participants include those with a BMI of 30.0 to 39.9 kgm or 27.0 to less than 30.0 kgm with at least one weight-related comorbidity such as prediabetes, hypertension, dyslipidemia, or obstructive sleep apnea. Participants receive oral CX11 tablets or matching placebo tablets once daily with meals. CX11 is also administered with a high fat, high calorie meal in some groups. The study compares multiple experimental groups receiving different doses of CX11 against a placebo group. The treatment period lasts 26 weeks with ongoing monitoring of safety and drug effects throughout. During the study, participants undergo regular assessments including body weight measurements to determine the percentage change from baseline at week 26. Researchers monitor safety and tolerability, pharmacokinetics, and pharmacodynamics through clinical evaluations and laboratory tests. The study is scheduled to complete in June 2027, with the primary outcome focused on body weight changes after 26 weeks of treatment.

A Study to Evaluate the Safety and Tolerability of Different Doses of CX11 Tablets