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Recruiting NCT07652047

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

Phase I Interventional Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CX11, Placebo, CX11.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1b Study Investigating Safety, Pharmacokinetics, and Pharmacodynamics of CX11 Tablets in Participants With Obesity or Overweight With Weight-Related Comorbidities

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.

Interventions

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

Primary outcome measures

  • Percentage change in body weight from baseline [Time frame: Week 26]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Corxel Investigational site — Las Vegas
  • Corxel Investigational Site — Austin

Identifiers

NCT: NCT07652047 · CX11102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗