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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of different doses of CX11 tablets and how well people tolerate them, compared with a placebo (a pill with no study drug). It also looks at how the body handles the drug and how the drug affects the body. It is for adults ages 18–55 with obesity, or with overweight and a weight-related health problem.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–55 years old.
  • Your BMI (a measure of weight compared with height) is 30.0–39.9, or it is 27.0 to less than 30.0 with at least one of the health problems listed below.
  • If your BMI is below 30.0, you have prediabetes (blood sugar above normal), high blood pressure, unhealthy blood fat levels, or obstructive sleep apnea (blocked breathing during sleep).
  • You have tried diet and exercise to lose weight without success, and your weight has stayed stable for the past 90 days.
  • You can follow the study steps and its rules about pregnancy and reproduction.

Who can't join

  • You have diabetes, or your obesity is caused by a hormone or genetic condition.
  • You recently used weight-loss drugs, GLP-1 medicines, blood sugar-lowering drugs, or an experimental treatment, or had weight-loss surgery or a weight-loss device.
  • You have major health risks involving the heart or heart rhythm, pancreas, gallbladder, digestive system, liver, kidneys, or thyroid.
  • You have major risks related to mental health, cancer, infection, an immune system that attacks the body, or abnormal lab tests.
  • You or a family member has had medullary thyroid cancer or multiple endocrine neoplasia (a condition that causes tumors in hormone-making glands).
  • You are pregnant or breastfeeding.
  • You recently used nicotine or drugs, or drink too much alcohol.
  • You have another condition or take a medicine that makes joining the study unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

NV

TX