HealhtyPhase 1NCT07224399
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
A Phase 1 study testing BGM1812 in people with Healhty and Overweight or Obesity, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healhty, 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 siteUnited States
- Study dates
- 9 Oct 2025to 31 Oct 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Body mass index (BMI) meeting one of the following requirements:
- Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR
- Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia (For Cohort 3- 6); OR
- Between ≥ 23.0 kg/m2 and < 27.0 kg/m2 healthy subjects (for Cohort 1 and Cohort 2)
- Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening
Who cannot join
- Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
- Known type I/II diabetes.
- Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight.
- History of acute or chronic pancreatitis or pancreatic injury.
- 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.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.
- Conditions
- Healhty, 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
Administered SC.
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 treatment adverse events
The relationship of each adverse event to the investigational product was assessed by the investigator
Measured: Predose up to 6 weeks (Part A) & 9 weeks (Part B)
Secondary outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812
PK: AUC of BGM1812
Measured: Predose through week 6 (Part A) & week 9 (Part B)
PK: Maximum Observed Concentration (Cmax) of BGM1812
PK: Cmax of BGM1812
Measured: Predose through week 6 (Part A) & week 9 (Part B)
Pharmacodynamics (PD): Change from baseline in fasting body weight
Pharmacodynamics (PD): Change from baseline in fasting body weight
Measured: Predose through week 6 (Part A) & week 9 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start9 Oct 2025
- Primary completion17 Jul 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealhtyStudies 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
- NCT07224399
- Sponsor's protocol ID
- BGM1812-P1-CPK01-US
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
- ClinicalTrials.gov ID
- NCT07224399
- Acronym / sponsor ID
- BGM1812-P1-CPK01-US
- Conditions
- Healhty, Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 4 Nov 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.
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.
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)
- 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.
- Body mass index (BMI) meeting one of the following requirements:
- Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening
Key exclusion criteria (5 listed)
- Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
- Known type I/II diabetes.
- Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight.
- History of acute or chronic pancreatitis or pancreatic injury.
- Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
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 |
|---|---|---|
| BGM1812Administered SC. | 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 treatment adverse events
Time frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B)
The relationship of each adverse event to the investigational product was assessed by the investigator
3 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812
Time frame: Predose through week 6 (Part A) & week 9 (Part B)
PK: Maximum Observed Concentration (Cmax) of BGM1812
Time frame: Predose through week 6 (Part A) & week 9 (Part B)
Pharmacodynamics (PD): Change from baseline in fasting body weight
Time frame: Predose through week 6 (Part A) & week 9 (Part B)
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 19 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 Healhty and Overweight or Obesity, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in United States.
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 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: under way, not looking for participants, as of the sponsor's last update on 19 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 United States. 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?
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?
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 treatment adverse events (time frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B)). 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 19 Oct 2026.