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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.