RECRUITING

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects

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Conditions

Non-diabetic Overweight or Obese

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral administrations in non-diabetic overweight or obese adult subjects.

Official Title

A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects

Quick Facts

Study Start:2025-08-11
Study Completion:2026-05-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07166081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) meeting one of the following requirements:
  2. 1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
  3. 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
  4. * Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening
  5. * 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.
  1. * Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
  2. * Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
  3. * Have received drugs that have an impact on body weight within 12 weeks before screening.
  4. * Known type I/II diabetes.
  5. * History of acute or chronic pancreatitis or pancreatic injury.
  6. * History of drug abuse or alcoholism at screening.

Contacts and Locations

Study Contact

MB ChB
CONTACT
240-673-0900
mohamed.al-ibrahim@pharmaron.com

Study Locations (Sites)

Pharmaron CPC, Inc
Baltimore, Maryland, 21201
United States

Collaborators and Investigators

Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2026-05-13

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2026-05-13

Terms related to this study

Additional Relevant MeSH Terms

  • Non-diabetic Overweight or Obese