CX11: CX11 tablets administered orally once daily (QD) with meals
Placebo: Matching placebo tablets administered orally once daily (QD) with meals
CX11: CX11 tablets administered orally once daily (QD) with high fat, high calorie meal
Study 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
Sex
FEMALE
Min age
18 Years
Max age
55 Years
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.
Primary outcome measure(s)
Percentage change in body weight from baseline — Week 26
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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