Phase 1 Obesity Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For healthy participants (certain study groups):
- People aged 18 to under 65, or aged 65 to 80 (depending on which group of the study)
- People with a body mass index (a measure of body weight relative to height) between 18.5 and 30, and a body weight of at least 50 kg for men or 45 kg for women
- People who have not smoked or used any tobacco or nicotine products in the month before screening
- People who are considered healthy based on the study's medical guidelines
For overweight participants with cardiovascular risk factors (a specific study group):
- People aged 18 to 65
- People with a body mass index between 30 and under 42
- People whose body weight has stayed roughly the same (less than 5% change) in the 3 months before screening
- People who have at least one risk factor for heart disease, such as high blood pressure or high cholesterol — if being treated for these, the treatment must have been stable for at least 3 months
- People with a blood inflammation marker (hsCRP) of 3 mg/L or higher (confirmed by a blood test at screening)
Who may not be able to join:
- People who score above a certain level on a standard scale used to assess thoughts of self-harm or suicide
- People who test positive at screening for hepatitis B, hepatitis C, HIV, syphilis, or tuberculosis
- People who are pregnant or currently breastfeeding
- People with a history of any brain or nervous system disorder, or any history of seizures
- People with clinically significant abnormal results on heart trace tests (ECG), physical examination, vital signs, or blood/lab tests at screening
- People who have had a significant heart or stroke-related event in the 6 months before screening
- People with a history of active or untreated cancer, or who have been in remission from a significant cancer for less than 5 years (skin cancers such as basal cell or squamous cell, or early-stage cervical cancer, may not apply — confirm with trial site)
- People who have taken part in another clinical trial involving a drug or device within the past 30 days (or longer, depending on the drug), or a biological medicine trial within the past 90 days (or longer, depending on the medicine), or who are currently in another study
- People for whom a lumbar puncture (a procedure involving the lower spine) would not be medically appropriate, as assessed by the study doctor
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +86 021-50831718
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The incidence of Adverse Events (AEs) after single or multiple doses of ISM8969 tablets.; Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examinations,12-lead ECG; C-SSRS Score(Type 1 to Type 5)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.