A Study to Evaluate the Safety and Tolerability of Different Doses of CX11 Tablets

Phase 1RecruitingNCT07652047

Corxel Pharmaceuticals90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity & Overweight

Interventions

CX11DRUG

CX11 tablets administered orally once daily (QD) with meals

PlaceboOTHER

Matching placebo tablets administered orally once daily (QD) with meals

CX11DRUG

CX11 tablets administered orally once daily (QD) with high fat, high calorie meal

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (2)

Corxel Investigational site

Las Vegas, Nevada, United States

RECRUITING

Corxel Investigational Site

Austin, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Percentage change in body weight from baseline

Time frame: Week 26

Central Contacts

Study coordinator

CONTACT

201-268-3723 information.center@corxelbio.com

Data from ClinicalTrials.gov

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