search
Back to results

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

Primary Purpose

Overweight or Obesity, Type2 Diabetes Mellitus

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSBR-1290
Placebo
Sponsored by
Gasherbrum Bio, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight or Obesity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria cohorts 1-4: Provided evidence of a signed consent Age ≥ 18 and ≤ 75 years Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 No nicotine use Have a suitable venous access for blood sampling Inclusion Criteria cohort 5: Men and women with T2DM of ≥6 months duration Age ≥ 18 and ≤ 75 years BMI ≥ 27 and ≤ 40 kg/m2 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: 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 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. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval 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 Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area Known hypersensitivity to any of the study drug ingredients Any other condition or prior therapy that would make the participant unsuitable for this study

Sites / Locations

  • Anaheim Clinical Trials
  • ProSciento, Inc
  • QPS Miami Research Associates
  • Progressive Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 25, 2023
Last Updated
September 5, 2023
Sponsor
Gasherbrum Bio, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT05762471
Brief Title
Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Official Title
A Phase 1b/2a, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus on Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gasherbrum Bio, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity, Type2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
This is a double-blind study in which the GSBR-1290 and the matching placebo are matching in appearance
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GSBR-1290
Intervention Description
Patients will receive GSBR-1290 or matching Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive GSBR-1290 or matching Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
Time Frame
31 days
Title
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
Time Frame
31 days
Title
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
Time Frame
31 days
Title
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma
Time Frame
31 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria cohorts 1-4: Provided evidence of a signed consent Age ≥ 18 and ≤ 75 years Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 No nicotine use Have a suitable venous access for blood sampling Inclusion Criteria cohort 5: Men and women with T2DM of ≥6 months duration Age ≥ 18 and ≤ 75 years BMI ≥ 27 and ≤ 40 kg/m2 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: 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 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. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval 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 Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area Known hypersensitivity to any of the study drug ingredients Any other condition or prior therapy that would make the participant unsuitable for this study
Facility Information:
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
ProSciento, Inc
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
QPS Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product have been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes: re-evaluating safety and efficacy end points already addressed in the product labelling, assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

Learn more about this trial

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

We'll reach out to this number within 24 hrs