Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type2 Diabetes Mellitus; Overweight or Obesity
• Interventions: Drug: GSBR-1290; Drug: Placebo

• Registration Number: NCT05762471
• Lead Sponsor: Gasherbrum Bio, Inc

Brief Summary

This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-09
• Status Verified: 2024-04
• Primary Completion: 2024-04-11
• Study Completion: 2024-04-11
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 2	Placebo	Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 3	Placebo	Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 5	Placebo	Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks
Cohort 4	Placebo	HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Cohort 2	GSBR-1290	Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 3	GSBR-1290	Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 1	GSBR-1290	Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 4	GSBR-1290	HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Cohort 5	GSBR-1290	Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks

Primary Outcome Measures

Name	Time	Method
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM	42 days

Secondary Outcome Measures

Name	Time	Method
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma	31 days
Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters	31 days
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters	31 days
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters	31 days

Trial Locations

Locations (4)

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

ProSciento, Inc; 🇺🇸 Chula Vista, California, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

QPS Miami Research Associates; 🇺🇸 Miami, Florida, United States