Obesity & Overweight
Conditions
Brief summary
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.
Interventions
CX11 tablets administered orally once daily (QD) with meals
Matching placebo tablets administered orally once daily (QD) with meals
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline | Week 26 |
Countries
United States