A Phase 1b Study Investigating Safety, Pharmacokinetics, and Pharmacodynamics of CX11 Tablets in Participants With Obesity or Overweight With Weight-Related Comorbidities
Corxel Pharmaceuticals
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.
Eligibility
- Age range
- 18–55 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DrugCX11
CX11 tablets administered orally once daily (QD) with meals
- OtherPlacebo
Matching placebo tablets administered orally once daily (QD) with meals
- DrugCX11
CX11 tablets administered orally once daily (QD) with high fat, high calorie meal
Locations (2)
- Corxel Investigational siteLas Vegas, Nevada
- Corxel Investigational SiteAustin, Texas