Tests BGM1812 injection for weight loss in adults with excess weight
Tests BGM1812 injection against placebo in adults who are overweight or obese.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Efficacy and Safety of BGM1812 Injection in Overweight or Obese Participants Without Diabetes
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07918625, who can take part
Where in China
- The Second Affiliated Hospital of Soochow UniversityChangsha, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BrightGene Bio-Medical Technology Co., Ltd.
- Trial code
- NCT07918625
- Record updated
- 5 November 2026
- Original description
To evaluate the efficacy of BGM1812 injection compared with placebo in reducing body weight in overweight or obese participants without diabetes after 26 weeks of treatment.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of BGM1812 Injection in Overweight or Obese Participants Without Diabetes.
To evaluate the efficacy of BGM1812 injection compared with placebo in reducing body weight in overweight or obese participants without diabetes after 26 weeks of treatment.
Inclusion: ○ Participants must be Chinese, non-diabetic, overweight or obese individuals aged 18 to 55 years (inclusive), as determined by the time of signing the informed consent form. Both men and women are eligible; Obese participants: BMI ≥ 28.0 kg/m²; or overweight participants: 24.0 kg/m² ≤ BMI < 28.0 kg/m² and have at least one of the following conditions: i. Pre-diabetes (impaired fasting glucose and/or impaired glucose tolerance), hypertension, non-alcoholic fatty liver disease, or dyslipidemia; ii. Weight-bearing joint pain; iii. Obesity-induced breathing difficulties or obstructive sleep apnea syndrome; Participants must have undergone at least 12 weeks of diet and exercise control before screening, with a weight change of less than 5.0% (self-reported), and be willing to continue with the same diet and exercise control during the trial period.
Exclusion: ● Within the previous 12 weeks, used drugs for weight control; Within the previous 12 weeks, used other drugs or supplements for weight loss purposes, or meal replacement products, including other prescription drugs, over-the-counter drugs, Chinese herbal medicines, supplements, meal replacement products (whether for weight loss purposes is determined by the prescription or product instructions); At the screening/baseline stage, any one of the following laboratory test indicators meets the following criteria: Glycated hemoglobin (HbA1c) ≥6.5%, fasting blood glucose ≥7.0 mmol/L, or 2-hour blood glucose of oral glucose tolerance test (OGTT) ≥11.1 mmol/L (during screening, participants with fasting blood glucose ranging from 6.1 to 6.9 mmol/L need to undergo the OGTT test); There is a history or evidence of any of the following diseases:1) (Interview) It belongs to a secondary disease or drug-induced obesity, including: elevated cortisol hormone (such as Cushing's syndrome), obesity caused by damage to the pituitary and hypothalamus, obesity caused by reducing or discontinuing weight loss drugs, etc.;2) (Interview/Examination) Previously or during screening diagnosed with type 1 or type 2 diabetes;3) (Interview) Previously diagnosed with acute or chronic pancreatitis, or pancreatic injury;4) (Interview) Previously diagnosed with thyroid C-cell carcinoma, MEN (multiple endocrine neoplasia) type 2A or 2B, or having a related family history; Previously had a moderate or severe depression history, or during screening the PHQ-9 (depression screening scale) questionnaire was ≥ 15 points, or had a history of other serious mental illness, or had suicidal tendencies or suicidal behavior.