Health TrialsbyHealthPanel

A Study of BGM0504 in Participants With Obesity

ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

● Able and willing to provide a written informed consent.

Male or female subjects, 18-65 years of age at the time of signing informed consent.

At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;

Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.

Disqualifiers

●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].

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGM0504

    Drug

    Administered SC

  • Tirzepatide

    Drug

    Administered SC

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: BGM0504Experimental treatment 1 intervention
Group B: TirzepatideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Body Weight

Change from baseline in body weight after 26 weeks of treatment

Time frame
Week 0, Week 26

Secondary outcomes

1

Change From Baseline in BMI

Change from baseline in BMI after 26 weeks of treatment

Time frame
Week 18, Week 26
2

Change From Baseline in Waist Circumference

Change from baseline in waist circumference after 26 weeks of treatment

Time frame
Week 18, Week 26
3

Change from Baseline in Systolic Blood Pressure (SBP)

Change from Baseline in SBP after 26 weeks of treatment

Time frame
Week 18, Week 26
4

Change from Baseline in Diastolic Blood Pressure (DBP)

Change from Baseline in DBP after 26 weeks of treatment

Time frame
Week 18, Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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