Phase 3 Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 75 years old (male or female) who are willing to follow the study requirements from start to finish.
• People with a body mass index (BMI) of 28.0 or higher at the screening visit.
• People who have been following a controlled diet and exercise plan for at least 3 months, with their weight changing by no more than 5 kg during that time.
• People whose sleep study results (a test called polysomnography) confirm they have obstructive sleep apnea (OSA).
• People who are able to use reliable contraception from the time of joining until 2 months after the last dose, and who have no plans to become pregnant or donate eggs or sperm during that period. Women who could become pregnant must have a negative pregnancy test within 3 days before being assigned to a treatment group and must not be breastfeeding.

Who may not be able to join:

• People whose blood test results show certain liver markers (ALT or AST) at 3 or more times the normal upper limit, or bilirubin at 2 or more times the normal upper limit.
• People whose kidney function test result (eGFR) is below 30 mL/min/1.73 m².
• People whose thyroid-stimulating hormone (TSH) level falls outside the range of 0.4 to 6.0 mIU/L.
• People with other abnormal blood test results that the study doctor believes could affect the safety or results of the trial.
• People whose heart tracing (ECG) shows significant abnormalities — such as signs of a past heart attack, serious irregular heartbeat, or certain types of heart rhythm problems — that the study doctor believes could affect their safety.
• People with poorly controlled blood pressure (top number 160 or higher, or bottom number 100 or higher).
• People who score 15 or higher on a standard depression questionnaire (called the PHQ-9).
• People with a hormonal or genetic condition that causes obesity.
• People who have diabetes.
• People whose sleep study shows central sleep apnea, mixed sleep apnea, or a breathing pattern called Cheyne-Stokes respiration, rather than obstructive sleep apnea.
• People with breathing or nerve/muscle conditions that the study doctor believes could interfere with trial results.
• People with a diagnosed sleep condition other than OSA, such as insomnia or excessive daytime sleepiness from another cause.
• People with a history of conditions that affect how the stomach empties, a history of severe digestive diseases, long-term use of medications that affect gut movement, or a history of stomach or bowel surgery.
• People with a history of pancreatitis, pancreatic injury, acute gallbladder inflammation, or gallbladder disease requiring treatment.
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related inherited condition (multiple endocrine neoplasia type 2).
• People who have had a severe infection, significant injury, or major or moderate surgery in the month before screening.
• People who have had a serious heart or stroke-related event in the 6 months before screening, including severe heart failure, unstable chest pain, stroke, mini-stroke (TIA), heart attack, serious abnormal heart rhythm, or heart surgery such as bypass or stenting.
• People who have been diagnosed with cancer in the past 5 years (with some exceptions for certain fully treated, localised cancers — confirm with trial site).
• People with current or suspected depression, bipolar disorder, suicidal thoughts, schizophrenia, or other serious mental health conditions.
• People with a known or suspected history of alcohol or drug misuse or addiction.
• People with active or chronic hepatitis or other serious liver disease (not including fatty liver disease).
• People with serious blood disorders such as aplastic anaemia, certain types of anaemia, or conditions that cause red blood cell breakdown (such as malaria).
• People with autoimmune diseases that require ongoing steroid or immune-suppressing treatment during the study.
• People who have used medications or treatments likely to cause significant weight change in the 3 months before screening.
• People using medications or treatments that the study doctor believes could affect how sleepiness is measured during the trial.
• People who have previously had, or are planning, weight-loss (bariatric) surgery (except liposuction performed more than 1 year ago).
• People who have had, or are planning, other device-based or endoscopic weight-loss procedures, or who had a related device removed in the past 6 months.
• People currently using continuous positive airway pressure (CPAP) or other OSA treatments — such as a mouth device or nerve stimulation — unless they are willing to stop using them at least 4 weeks before screening and throughout the study.
• People who need supplemental oxygen.
• People who have taken part in another clinical trial (drug or medical device) within 3 months before screening, or who are still within a certain washout period for a previous trial drug (whichever is longer).
• People who have donated blood, lost 400 mL or more of blood, or received a blood transfusion in the 3 months before screening.
• People who have planned surgery during the trial period (except minor procedures the study doctor considers unlikely to affect results).
• People who are unable to fully understand or participate in the trial due to cognitive or language difficulties.
• People with any medical, psychological, social, or other condition that the study doctor believes could affect safety or interfere with trial results.
• Trial site staff and investigators directly involved in running the study, their immediate family members, and employees of the sponsoring company (Hengrui).

Important: Always verify eligibility with the trial site directly before applying.