A Study Comparing the Effects of BGM0504 Injection and Semaglutide Injection on Obese Subjects.

NCT07836140 | Completed Phase 2

• 1 other identifier: BGM0504-IIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

An Investigator-Initiated, Randomized, Open-Label, Active-Controlled Study Comparing the Effects of BGM0504 Injection versus Semaglutide Injection on Insulin Sensitivity and Body Weight in Obese Subjects

Conditions

Obesity / Overweight

Keywords

Obesity

Outcome Measures

Primary Outcomes (3)

• HOMA2-β index

  Change in the HOMA2-β (steady-state model for beta-cell function assessment) index from baseline at Week 16 of the target dosage

  Target dose at week 16

• HOMA2-IR

  Change in the HOMA2-IR (homeostasis model assessment of insulin resistance) index from baseline at Week 16 of the target dose

  Target dose at week 16

• MFI

  Target dose: relative percentage change in skeletal muscle fat infiltration (MFI) from baseline at Week 16

  Target dose at week 16

Secondary Outcomes (17)

• Fasting insulin

  Target dose at week 16

• Fasting blood glucose

  Target dose at week 16

• Fasting C-peptide

  Target dose at week 16

• Fasting glucagon

  Target dose at week 16

• OGTT

  At 30 minutes, 60 minutes, and 120 minutes compared to the baseline.

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

Multiple ascending doses of Semaglutide administered SC

Drug: semaglutide

BGM0504

EXPERIMENTAL

Multiple ascending doses of BGM0504 administered SC

Drug: BGM0504 Administered SC

Interventions

semaglutide DRUG

Multiple ascending doses of semaglutide administered SC

Semaglutide

BGM0504 Administered SC DRUG

Multiple ascending doses of BGM0504 administered SC

BGM0504

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: April 22, 2024
• Primary Completion: April 25, 2025
• Study Completion: April 30, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)