Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Launched by GASHERBRUM BIO, INC., A WHOLLY OWNED SUBSIDIARY OF STRUCTURE THERAPEUTICS · Feb 28, 2023
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria cohorts 1-4:
- • 1. Provided evidence of a signed consent
- • 2. Age ≥ 18 and ≤ 75 years
- • 3. Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2
- • 4. No nicotine use
- • 5. Have a suitable venous access for blood sampling
- Inclusion Criteria cohort 5:
- • 1. Men and women with T2DM of ≥6 months duration
- • 2. Age ≥ 18 and ≤ 75 years
- • 3. BMI ≥ 27 and ≤ 40 kg/m2
- • 4. Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%.
- Exclusion Criteria:
- • 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months
- • 2. A sitting BP after resting for 5 minutes \> 160mm Hg systolic or \> 100 mm Hg diastolic or an apical pulse rate \<50 or \>100 beats per minute.
- • 3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
- • 4. Liver function test results elevated \> 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
- • 5. Estimated glomerular filtration rate \< 60mL/min/1.73 m2 body surface area
- • 6. Known hypersensitivity to any of the study drug ingredients
- • 7. Any other condition or prior therapy that would make the participant unsuitable for this study
About Gasherbrum Bio, Inc., A Wholly Owned Subsidiary Of Structure Therapeutics
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics, is a biopharmaceutical company dedicated to advancing innovative therapies for unmet medical needs. With a focus on leveraging cutting-edge science and technology, Gasherbrum Bio is committed to the development of novel treatments that aim to improve patient outcomes across various therapeutic areas. The company combines expertise in drug development with a strategic approach to clinical research, ensuring rigorous adherence to regulatory standards and a strong commitment to ethical practices in all clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Port Orange, Florida, United States
Anaheim, California, United States
Miami, Florida, United States
Chula Vista, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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