Phase 1 Obesity Trial, Recruiting NCT07355738 Sponsor: Gan & Lee Pharmaceuticals. Condition: Obesity
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Phase 1 Obesity Trial, Recruiting

NCT07355738
Recruiting Phase 1

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:

  • You are willing to sign a consent form, can receive injections under the skin, understand what the trial involves, and are able to follow all rules set out in the study.
  • You are male and between 18 and 50 years old (inclusive) at the time of signing the consent form.
  • You weigh at least 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² at the screening stage.
  • You have no plans to father a child or donate sperm from the time of signing the consent form until 8 weeks after your last dose, and you are willing to use effective contraception during this time.

Who may not be able to join:

  • You have any significant abnormal results from physical checks, vital signs, blood tests, heart tracing (ECG), abdominal scan, or chest X-ray during screening, as decided by the study doctor.
  • You test positive for hepatitis B, hepatitis C, HIV, or syphilis.
  • You have a history of, or currently have, significant problems with your heart and circulation, kidneys, digestive system, lungs, nervous system, hormones, or mental health.
  • You have a history of pancreatitis (inflammation of the pancreas) or pancreatic injury at any point before screening.
  • You or a family member have a history of a type of thyroid cancer called medullary thyroid carcinoma, or a condition called multiple endocrine neoplasia type 2.
  • You have taken any medicines in the past 4 weeks that affect how the body processes drugs, or you have become ill or started new medication between screening and the start of the trial.
  • You have had a serious or unexplained infection within the 4 weeks before screening.
  • You have had major surgery in the 6 months before screening, or you have surgery or a hospital stay planned during the study.
  • You are known or suspected to be allergic to any ingredient in the study drug (a type of medicine called a GLP-1 receptor agonist).
  • You have taken any prescription medicines, over-the-counter medicines, or herbal remedies in the 2 weeks before screening, or have used GLP-1 receptor agonist medicines (or similar medicines) in the 3 months before screening.
  • You have had a vaccination in the month before screening, or you have a vaccination planned during the study.
  • You have donated blood or lost 400 mL or more of blood in the 3 months before screening, or you plan to donate blood during the study or within 8 weeks after the study ends.
  • You have a history of drug abuse, or your drug screening test at the start of the study comes back positive.
  • You have a history of heavy alcohol use in the 3 months before screening (more than 14 units per week on average), or you have consumed alcohol in the 48 hours before receiving the study drug, or your breath alcohol test at screening is abnormal.
  • You have smoked more than 5 cigarettes a day on average in the 3 months before screening, or you are unwilling to avoid smoking for the duration of the study.
  • You have done intense physical exercise in the 48 hours before receiving the study drug, or there are other factors that could affect how the drug moves through your body.
  • You have eaten or drunk grapefruit, grapefruit products, coffee, tea, cola, chocolate, or other caffeine-containing products in the 48 hours before receiving the study drug.
  • You have special dietary needs that prevent you from following a standard study diet, or you are lactose intolerant.
  • You have a fear of needles or blood, or you have difficulty with or cannot tolerate having blood taken from a vein.
  • You are an investigator or employee at the study site, or a family member of one.
  • You have taken part in another clinical trial of a medicine or medical device in the 3 months before screening (or within 5 half-lives of the previous study drug, whichever is longer), or you plan to join another clinical trial before completing all assessments in this study.

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 2 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Gan & Lee Pharmaceuticals.
Registry
ClinicalTrials.gov
Start date
9 January 2026
Est. completion
20 May 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

the maximum concentration (Cmax); the area under the concentration-time curve during a dosing interval (AUC0-t); the area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0-∞)

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: 2 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