NCT06973681

Brief Summary

To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
Last Updated

May 15, 2025

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 14, 2025

Last Update Submit

May 14, 2025

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

  • Percentage change in body weight

    Percentage change from baseline in body weight after 24 weeks of treatment.

    Week 0 to Week 24

Secondary Outcomes (4)

  • Proportion of Subjects with weight loss of ≥5%

    Week 0 to Week 24

  • Change from baseline in waist circumference

    Week 0 to Week 24

  • Change from baseline in BMI

    Week 0 to Week 24

  • Change from baseline in fasting plasma glucose (FPG)

    Week 0 to Week 24

Study Arms (4)

5 mg BGM0504

EXPERIMENTAL

5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Drug: BGM0504

10 mg BGM0504

EXPERIMENTAL

10 mg BGM0504 administered SC once a week.

Drug: BGM0504

15 mg BGM0504

EXPERIMENTAL

15 mg BGM0504 administered SC once a week.

Drug: BGM0504

Placebo

PLACEBO COMPARATOR

Placebo administered SC once a week.

Drug: Placebo

Interventions

BGM0504DRUG

Administered SC

10 mg BGM0504
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI \< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.Controlled by diet and exercise alone for at least 12 weeks prior to Screening with \<5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, China

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 15, 2025

Study Start

October 13, 2023

Primary Completion

September 13, 2024

Study Completion

September 13, 2024

Last Updated

May 15, 2025

Record last verified: 2023-06

Locations

CN(1)