New drug BGM0504 takes aim at obesity and insulin resistance

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1.Chinese adult participants aged 18 to 65 years (inclusive) with obesity, both male and female; 2.Obese individuals: BMI ≥ 30.0 kg/m², or BMI ≥ 27.0 kg/m² with at least one weight-related comorbidity (such as prediabetes, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome, metabolic abnormalities, etc.); 3.Prior to screening, participants must have maintained weight control through diet and exercise alone for at least 12 weeks, with a reported weight change of less than 5.0%, and must be able to continue their existing diet and exercise regimen for weight management throughout the trial period； 4.MRI (Magnetic Resonance Imaging scan) has no contraindications (e.g., use of pacemakers and metal implants, or claustrophobia that hinders completion of the MRI examination)； 5.Fully understand the purpose, nature, methods, and potential adverse reactions of the trial, be capable of completing the trial in accordance with the protocol requirements, voluntarily serve as a study participant, and sign the informed consent form； 6.Individuals who, from the time of signing the informed consent form until one month after the conclusion of the study, have no plans for pregnancy, voluntarily adopt effective contraceptive measures to prevent pregnancy or impregnation of their partner, and have no plans to donate sperm or eggs； Note: The percentage change in body weight is calculated as follows: (Body weight 12 weeks prior to screening - Body weight at screening) / Body weight 12 weeks prior to screening × 100%. Exclusion Criteria: * 1.Subjects with uncontrolled hypertension at screening (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening) or those with untreated blood pressure meeting the above criteria； 2.During screening, there was thyroid dysfunction that could not be controlled with a stable medication dose, or thyroid function test results showed clinically significant abnormalities requiring the initiation of treatment； 3.During screening, abdominal ultrasound indicates the presence of gallstones or polyps, or there are clinical symptoms of gallbladder disease at the time of screening； 4.During screening, severe chronic complications of diabetes requiring acute treatment are identified, such as diabetic nephropathy, proliferative retinopathy, or non-proliferative diabetic retinopathy; peripheral vascular disease leading to amputation, chronic foot ulcers, or intermittent claudication; and painful diabetic neuropathy； 5.It is known that the individual has an allergic constitution (allergic to three or more foods or medications), is allergic to GLP-1 receptor agonist drugs, or suffers from severe allergic diseases (asthma, urticaria, eczema, dermatitis, etc.) during screening； 6.Individuals with a history of severe diseases affecting the nervous, respiratory, immune, hepatic, renal, or other organ systems are deemed unsuitable for participation in the trial based on investigator assessment； 7.Individuals with severe mental illness or language barriers who are unwilling or unable to fully understand and cooperate during screening； 8.Individuals who tested positive for drugs in urine screening or alcohol in breath testing at baseline； 9.History of substance abuse； 10.Select individuals who have participated in any clinical study within the past three months and received intervention with an investigational drug or medical device； 11.Female subjects who are pregnant or breastfeeding； Note：The researchers believe that the subject has any other factors that would make participation in this trial inappropriate.