A Study to Evaluate the Safety and Tolerability of Different Doses of CX11 Tablets
Recruiting · NCT07652047 · Interventional (participants receive a specific treatment) · Lead sponsor: Corxel Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
CX11Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 2 US states.
- Corxel Investigational site - Las Vegas, Nevada, United States
- Corxel Investigational Site - Austin, Texas, United States