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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

NCT ID: NCT07224399

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-09

Study Completion Date

2026-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Healhty Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BGM1812 (Part A)

Single ascending doses of BGM1812 administered subcutaneously (SC).

Group Type EXPERIMENTAL

BGM1812

Intervention Type DRUG

Administered SC.

Placebo (Part A)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

BGM1812 (Part B)

Multiple ascending doses of BGM1812 administered SC.

Group Type EXPERIMENTAL

BGM1812

Intervention Type DRUG

Administered SC.

Placebo (Part B)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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BGM1812

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

BGM1812

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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:

1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR
2. 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
3. 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BrightGene Bio-Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pharmaron CPC, Inc

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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MD, MPH, FACP

Role: primary

Other Identifiers

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BGM1812-P1-CPK01-US

Identifier Type: -

Identifier Source: org_study_id