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

A Phase 1b Study Investigating Safety, Pharmacokinetics, and Pharmacodynamics of CX11 Tablets in Participants With Obesity or Overweight With Weight-Related Comorbidities

A multi-center, randomized, placebo-controlled, double-blinded (within cohorts), Sponsor-unblinded, Phase 1b study to explore the safety, pharmacokinetics, and pharmacodynamics of CX11 tablets in participants with obesity or overweight with weight-related comorbidities.

Inclusion Criteria:

• Male or female, 18-55 years.
• BMI ≥30.0 to ≤39.9 kg/m², or ≥27.0 to <30.0 kg/m² with at least 1 weight-related comorbidity: prediabetes, hypertension, dyslipidemia, or obstructive sleep apnea.
• Prior unsuccessful diet/exercise weight-loss attempt and stable body weight within 90 days.
• Able to comply with study procedures and reproductive requirements.

Exclusion Criteria:

• Diabetes or obesity due to endocrine/genetic causes.
• Recent weight-loss drugs, GLP-1-based therapy, glucose-lowering drugs, obesity surgery/device, or investigational treatment.
• Significant cardiovascular, ECG/QT, pancreatic, gallbladder, GI, liver, kidney, thyroid, psychiatric, malignant, infectious, autoimmune, or lab abnormality risks.
• Personal/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
• Pregnancy, breastfeeding, recent nicotine/drug use, excessive alcohol use, or any condition/medication making participation inappropriate.