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

Purpose

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.

Condition

  • Obesity & Overweight

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
Female
Accepts 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 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo group 		Placebo
  • Other: Placebo
    Matching placebo tablets administered orally once daily (QD) with meals
Experimental
CX11 Group A
  • Drug: CX11
    CX11 tablets administered orally once daily (QD) with meals
  • Drug: CX11
    CX11 tablets administered orally once daily (QD) with high fat, high calorie meal
Experimental
CX11 Group B
  • Drug: CX11
    CX11 tablets administered orally once daily (QD) with meals
  • Drug: CX11
    CX11 tablets administered orally once daily (QD) with high fat, high calorie meal
Experimental
CX11 Group C
  • Drug: CX11
    CX11 tablets administered orally once daily (QD) with meals
  • Drug: CX11
    CX11 tablets administered orally once daily (QD) with high fat, high calorie meal

Recruiting Locations

Corxel Investigational site
Las Vegas, Nevada 89113
Contact:
Study Director
201-268-3723
information.center@corxelbio.com

Corxel Investigational Site
Austin, Texas 78744
Contact:
Study Director
201-268-3723
information.center@corxelbio.com

More Details

Status
Recruiting
Sponsor
Corxel Pharmaceuticals

Study Contact

Study coordinator
201-268-3723
information.center@corxelbio.com