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Overweight or ObesePhase 1NCT06920056

A Study of BGM0504 in Overweight or Obese Participants

A Phase 1 study testing Paracetamol, Metformin Hydrochloride and Warfarin in people with Overweight or Obese, run by BrightGene Bio-Medical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Overweight or Obese
What is being tested?
Paracetamol, Metformin Hydrochloride and Warfarin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
25 Mar 2025to 25 Jul 2025
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
  • No healthy volunteers
  • Adult

Inclusion Criteria: √ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (<) 28 kg/m².

√ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

Exclusion Criteria: √ History of chronic or acute pancreatitis.

  • History of severe drug allergy or specific allergic disease or severe allergies.
  • Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
  • History of malignant tumors [except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma].
  • Suspected or confirmed history of alcohol or drug abuse;
  • Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
  • Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
  • Pregnant or lactating woman.
  • Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

    Kunming, Yunnan, 650100

Other trials in China

About this study

Official title: A Single Center, Open-label, Fixed Sequence Trial, Investigating the Influence of BGM0504 Injection on Gastric Emptying and Pharmacokinetics of Metformin and Warfarin in Overweight or Obese Participants

The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants

Being tested
Paracetamol, Metformin Hydrochloride, Warfarin, BGM0504
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParacetamolDrug

    oral, postprandial

  • Metformin HydrochlorideDrug

    Oral , Fasting

  • WarfarinDrug

    Oral , Fasting

  • BGM0504Drug

    Administered SC

Study groups in NCT06920056
Study groupRoleWhat they receive
Paracetamol + Metformin + Warfarin +BGM0504ExperimentalParticipants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77. Participants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW).
Receives: Drug: Paracetamol; Drug: Metformin Hydrochloride; Drug: Warfarin; Drug: BGM0504

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol

    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Paracetamol

    Measured: From Day1 to Day72

  2. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol

    Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol

    Measured: From Day1 to Day72

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin

    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Metformin

    Measured: From Day4 to Day76

  4. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin

    Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin

    Measured: From Day4 to Day76

  5. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin

    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin

    Measured: From Day7 to Day84

  6. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin

    Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin

    Measured: From Day7 to Day84

Secondary outcomes (3)

  1. Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504

    Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504

    Measured: From Day14 to Day69

  2. Time to Maximum Concentration (Tmax) of Metformin and Warfarin

    Time to Maximum Concentration (Tmax) of Metformin and Warfarin

    Measured: From Day1 to Day84

  3. Terminal Half-life (t1/2) of Paracetamol

    Terminal Half-life (t1/2) of Paracetamol

    Measured: From Day1 to Day72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start25 Mar 2025
  3. Primary completion25 Jul 2025
  4. Study completion25 Jul 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06920056
Sponsor's protocol ID
BGM0504-DDI
Status last verified
Feb 2025
First submitted
27 Mar 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paracetamol, Metformin Hydrochloride and Warfarin in people with Overweight or Obese, 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?

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 13 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. 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?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol (time frame: From Day1 to Day72). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06920056.

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 13 Oct 2026.

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