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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

CX11
Drug
CX11 tablets administered orally once daily (QD) with meals
Placebo
Other intervention
Matching placebo tablets administered orally once daily (QD) with meals
CX11
Drug
CX11 tablets administered orally once daily (QD) with high fat, high calorie meal

Treatment groups

90 Participants

are divided into 4 treatment groups

Group A: Placebo groupPlacebo comparator 1 intervention

Group B: CX11 Group AExperimental treatment 1 intervention

Group C: CX11 Group BExperimental treatment 1 intervention

Group D: CX11 Group CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percentage change in body weight from baseline

Time frame

Week 26

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corxel Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

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