A Study to Evaluate the Safety and Tolerability of Different Doses of CX11 Tablets
ConditionObesity & Overweight
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorCorxel Pharmaceuticals
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CX11
- Placebo
- CX11
Treatment groups
90 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov