Overweight or Obese Participants Without DiabetesPhase 2NCT07918625
A Study to Evaluate Efficacy and Safety of BGM1812 Injection in Overweight or Obese Participants Without Diabetes
A Phase 2 study testing BGM1812 injection / plcaebo in people with Overweight or Obese Participants Without Diabetes, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight or Obese Participants Without Diabetes
- What is being tested?
- BGM1812 injection / plcaebo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ○ 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.
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Soochow University
Changsha, Hunan, 410013
Jin, +86 13637491977, ping.jin06@csu.edu.cn
About this study
Official title: 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.
- Being tested
- BGM1812 injection / plcaebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM1812 injection / plcaeboDrug
Once weekly or once every two weeks, administered continuously for 24 weeks.
BGM1812 injection / plcaeboDrug
Once weekly or once every two weeks, administered continuously for 24 weeks.
BGM1812 injection / plcaeboDrug
Once weekly or once every two weeks, administered continuously for 24 weeks.
BGM1812 injection / plcaeboDrug
Once weekly or once every two weeks, administered continuously for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 0.6mg BGM1812 | Experimental | Not described Receives: Drug: BGM1812 injection / plcaebo |
| Group 2: 1.2mg BGM1812 | Experimental | Not described Receives: Drug: BGM1812 injection / plcaebo |
| Group 3: 2.4mg BGM1812 | Experimental | Not described Receives: Drug: BGM1812 injection / plcaebo |
| Group 4: 2.4mg BGM1812 | Experimental | Not described Receives: Drug: BGM1812 injection / plcaebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Percentage change in fasting body weight from baseline after 24 weeks of treatment
Measured: 24 weeks
Secondary outcomes (1)
Change from Baseline in Body Weight
Changes in fasting body weight from baseline at 4, 8, 12, 16, 20, and 24 weeks after drug administration.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or Obese Participants Without DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918625
- Sponsor's protocol ID
- BGM1812-II-Obesity
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07918625
- Acronym / sponsor ID
- BGM1812-II-Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 0.6mg BGM1812 | Experimental | Drug: BGM1812 injection / plcaebo |
| Group 2: 1.2mg BGM1812 | Experimental | Drug: BGM1812 injection / plcaebo |
| Group 3: 2.4mg BGM1812 | Experimental | Drug: BGM1812 injection / plcaebo |
| Group 4: 2.4mg BGM1812 | Experimental | Drug: BGM1812 injection / plcaebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ○ 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.
Key exclusion criteria (5 listed)
- ● Within the previous 12 weeks, used drugs for weight control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGM1812 injection / plcaeboOnce weekly or once every two weeks, administered continuously for 24 weeks. | Drug | Group 1: 0.6mg BGM1812 |
| BGM1812 injection / plcaeboOnce weekly or once every two weeks, administered continuously for 24 weeks. | Drug | Group 2: 1.2mg BGM1812 |
| BGM1812 injection / plcaeboOnce weekly or once every two weeks, administered continuously for 24 weeks. | Drug | Group 3: 2.4mg BGM1812 |
| BGM1812 injection / plcaeboOnce weekly or once every two weeks, administered continuously for 24 weeks. | Drug | Group 4: 2.4mg BGM1812 |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: 24 weeks
Percentage change in fasting body weight from baseline after 24 weeks of treatment
1 secondary outcome
Change from Baseline in Body Weight
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGM1812 injection / plcaebo in people with Overweight or Obese Participants Without Diabetes, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin (+86 13637491977, ping.jin06@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in Body Weight (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.