Phase 1 Obesity Trial, Recruiting NCT07581431 Sponsor: InSilico Medicine Hong Kong Limited Condition: Obesity
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Phase 1 Obesity Trial, Recruiting

NCT07581431
Recruiting Phase 1 🇦🇺 Australian site

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 7 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 021-50831718

Australian sites

Nucleus Network Pty Ltd., Melbourne, Victoria

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

Status
Recruiting
Phase
Phase 1
Sponsor
InSilico Medicine Hong Kong Limited
Registry
ClinicalTrials.gov
Start date
15 June 2026
Est. completion
29 January 2027

Where this trial is recruiting

🇦🇺 Australia

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov