Overweight or ObesityPhase 1NCT07294235
A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants
A Phase 1 study testing BGM1812 in people with Overweight or Obesity, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- BGM1812
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to 5 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;
- Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI < 24 kg/m²（BMI = weight/height²）;
- Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m²;
- (Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
- Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
- Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose.
Who cannot join
- Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.
- Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
- 12-lead ECG shows ventricular heart rate < 50 beats/min or > 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF> 470ms for women or > 450ms for men, pre-excitation syndrome or other significant arrhythmias.
- Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
- Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.
- Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.
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- Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.
- Positive urine drug test or alcohol serum test result at screening or at baseline.
- Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Yunnan University of Chinese Medicine
Kunming, Yunnan, 650000
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants
The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.
- Conditions
- Overweight or Obesity
- Being tested
- BGM1812, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGM1812Drug
AdministeredSC
PlaceboDrug
Administered SC
BGM1812Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| BGM1812(Part A) | Experimental | Single ascending doses of BGM1812 administered subcutaneously (SC) Receives: Drug: BGM1812 |
| Placebo (Part A) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| BGM1812 (Part B) | Experimental | Multiple ascending doses of BGM1812 administered SC. Receives: Drug: BGM1812 |
| Placebo (Part B) | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator
Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0
Measured: Baseline to Study Completion (Up to 6-9weeks)
Secondary outcomes (8)
Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812
PK Cmax of BGM1812
Measured: Baseline to Study Completion (Up to 6-9weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812
PK:AUC of BGM1812
Measured: Baseline to Study Completion (Up to 6-9weeks)
Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812
PD: Changes in fasting blood glucosebefore and after administration, and differences in the amount of change among different dose groups
Measured: Baseline to Study Completion (Up to 6-9weeks)
PD:C-Peptide of BGM1812
PD: Changes in C-peptide before and after administration, and differences in the amount of change among different dose groups
Measured: Baseline to Study Completion (Up to 6-9weeks)
PD: Insulin of BGM1812
PD: Changes in insulin before and after administration, and differences in the amount of change among different dose groups
Measured: Baseline to Study Completion (Up to 6-9weeks)
PD: Body Weight of BGM1812
PD: Changes in body weight before and after administration, and differences in the amount of change among different dose groupsPD: Changes in body weight before and after administration, and differences in the amount of change among different dose groups
Measured: Baseline to Study Completion (Up to 6-9weeks)
PD: Waist Circumference of BGM1812
PD: Changes in waist circumference before and after administration, and differences in the amount of change among different dose groups
Measured: Baseline to Study Completion (Up to 6-9weeks)
Anti-drug antibodies (ADA) of the study drug and their titers
Detect the anti-drug antibodies (ADA) of the study drug and their titers; if the ADA is positive, neutralizing antibodies (NAb) will be further detected.
Measured: Baseline to Study Completion (Up to 6-9weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start5 Dec 2025
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
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
- NCT07294235
- Sponsor's protocol ID
- BGM1812-CPK-101
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2025
- Last updated
- 15 Oct 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of BGM1812 in Healthy and Non-diabetic Overweight or Obese Chinese Participants
- ClinicalTrials.gov ID
- NCT07294235
- Acronym / sponsor ID
- BGM1812-CPK-101
- Conditions
- Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 19 Dec 2025 (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.
The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BGM1812(Part A) | Experimental | Drug: BGM1812Single ascending doses of BGM1812 administered subcutaneously (SC) |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| BGM1812 (Part B) | Experimental | Drug: BGM1812Multiple ascending doses of BGM1812 administered SC. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;
- Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI < 24 kg/m²（BMI = weight/height²）;
- Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m²;
- (Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
- Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
Key exclusion criteria (9 listed)
- Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.
- Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
- 12-lead ECG shows ventricular heart rate < 50 beats/min or > 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF> 470ms for women or > 450ms for men, pre-excitation syndrome or other significant arrhythmias.
- Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
- Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.
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 |
|---|---|---|
| BGM1812AdministeredSC | Drug | BGM1812(Part A) |
| PlaceboAdministered SC | Drug | Placebo (Part A) |
| BGM1812Administered SC | Drug | BGM1812 (Part B) |
| PlaceboAdministered SC | Drug | Placebo (Part B) |
Primary outcome
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0
8 secondary outcomes
Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD:C-Peptide of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Insulin of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Body Weight of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Waist Circumference of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Anti-drug antibodies (ADA) of the study drug and their titers
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGM1812 in people with Overweight or Obesity, 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 15 Oct 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator (time frame: Baseline to Study Completion (Up to 6-9weeks)). 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 15 Oct 2026.