Phase 1 Obesity Trial, Recruiting NCT07382908 Sponsor: BrightGene Bio-Medical Technology Co., Ltd. Condition: Obesity
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Phase 1 Obesity Trial, Recruiting

NCT07382908
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:

  • People aged 18 to 55 years old (inclusive)
  • Men who weigh at least 50 kg, or women who weigh at least 45 kg, and whose BMI falls in the overweight range (24.0 to below 28.0) or obese range (28.0 or above)
  • People who do not plan to become pregnant (or cause a partner to become pregnant) and are willing to use effective contraception from signing the consent form until 3 months after receiving the study dose, and who do not plan to donate sperm or eggs during that time
  • People who fully understand the purpose, nature, methods, and possible side effects of the trial, are able to follow the study plan, have good general health habits, can communicate well with the research team, and are willing to sign a consent form

Who may not be able to join:

  • People with a history of severe allergies, severe allergic conditions (such as asthma, hives, or eczema), allergy to two or more foods or drugs, or a known or suspected allergy to any ingredient in BGM0504 Injection
  • People who have previously been diagnosed with type 1 or type 2 diabetes, or whose HbA1c (a blood sugar measure) is found to be significantly abnormal at the screening stage
  • People with a family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a condition called multiple endocrine neoplasia type 2
  • People with a history of acute or chronic pancreatitis, pancreatic injury, or other factors considered to raise the risk of pancreatitis
  • People whose screening results or medical history show digestive system conditions that may increase risk during the trial (confirm with trial site)
  • People whose screening blood tests are positive for hepatitis B surface antigen, hepatitis C antibodies, syphilis antibodies, or HIV antibodies
  • People who have taken part in another clinical trial involving a drug or medical device and received the study treatment within the 3 months before screening
  • People who have consumed, or plan to consume, certain foods or drinks within 48 hours before dosing — including dragon fruit (pitaya), mango, grapefruit, pomelo or their juices, high-purine foods such as organ meats, seafood, or chocolate, as well as caffeine- or alcohol-containing drinks — or who are unwilling to avoid these during the in-clinic period
  • Women who are pregnant or breastfeeding, or who have a positive pregnancy test at screening
  • People with any other condition that the investigator considers makes participation unsuitable, or who need to withdraw for personal reasons

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 12 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
BrightGene Bio-Medical Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
23 December 2025
Est. completion
12 February 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Peak Plasma Concentration (Cmax); Area under the plasma concentration versus time curve (AUC)0-t

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: 12 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