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A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06139055
Recruitment Status : Active, not recruiting
First Posted : November 18, 2023
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
Gasherbrum Bio, Inc

Study Description
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Brief Summary:
The purpose of this study is to compare the safety, tolerability, pharmacokinetic (PK), and comparative bioavailability of repeated administration of GSBR-1290 in healthy overweight/obese participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GSBR-1290 (Capsule/Tablet) Drug: GSBR-1290 Drug: Placebo Drug: Placebo (Capsule/Tablet) Phase 1

Detailed Description:
This is a 2-part study in which Part 1 will compare the PK of GSBR-1290, administered as tablet and capsule, using a 2-period, 2-sequence, crossover design in approximately 16 healthy overweight/obese participants. Part 2 will evaluate multiple-ascending doses of GSBR-1290 tablet in 3 cohorts, using 3 different titration regimens. Secondly in Part 2, the study will evaluate the comparative bioavailability of GSBR-1290 tablet versus capsule at a potentially clinically efficacious dose at steady state in Cohort 3.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part 1 is open-label, 2-period, 2-sequence, cross-over and Part 2 is double blinded
Primary Purpose: Treatment
Official Title: A 2-part, Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Comparative Bioavailability of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants
Actual Study Start Date : October 2, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 Tablet
Participants will receive a single dose of GSBR-1290 oral capsule formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral tablet formulation on Day 8 (Day 1 of Treatment Period 2).
 Drug: GSBR-1290 (Capsule/Tablet)
Participants will receive GSBR-1290 oral capsules or tablets.
Experimental: Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 Capsule
Participants will receive a single dose of GSBR-1290 oral tablet formulation on Day 1 in Treatment Period 1 followed by GSBR-1290 oral capsule formulation on Day 8 (Day 1 of Treatment Period 2).
 Drug: GSBR-1290 (Capsule/Tablet)
Participants will receive GSBR-1290 oral capsules or tablets.
Experimental: Part 2 (Cohort 1): GSBR-1290/Placebo Tablet
Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.
 Drug: GSBR-1290
Participants will receive GSBR-1290 oral tablets.

Drug: Placebo
Participants will receive matching-placebo oral tablets.
Experimental: Part 2 (Cohort 2): GSBR-1290/Placebo Tablet
Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.
 Drug: GSBR-1290
Participants will receive GSBR-1290 oral tablets.

Drug: Placebo
Participants will receive matching-placebo oral tablets.
Experimental: Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule
Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks. In the last 4 weeks, participants will be further randomized to GSBR-1290 capsules or tablets or matching-placebo at Week 9 to 10 followed by alternate (capsule or tablet) formulation of either GSBR-1290 or placebo at Week 11 to 12.
 Drug: GSBR-1290 (Capsule/Tablet)
Participants will receive GSBR-1290 oral capsules or tablets.

Drug: Placebo (Capsule/Tablet)
Participants will receive matching-placebo oral capsules or tablets.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1: Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters [ Time Frame: From start of study drug up to Day 10 ]
  2. Part 1: Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 10 ]
  3. Part 1: Analysis of Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 10 ]
  4. Part 1: Analysis of Area Under the Plasma Concentration-time Curve From 0 to infinity (AUC0-inf) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 10 ]
  5. Part 1: Analysis of Apparent Terminal Elimination Half-life (t1/2) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 10 ]
  6. Part 1: Analysis of Total Apparent Body Clearance (CL/F) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 10 ]
  7. Part 1: Analysis of Apparent Volume of Distribution (Vz/F) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 10 ]
  8. Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: From start of study drug up to End of study (EOS) in Part 2 (up to Day 98) ]
  9. Part 2: Number of Participants With Severity of AEs [ Time Frame: From start of study drug up to EOS in Part 2 (up to Day 98) ]
  10. Part 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: From start of study drug up to EOS in Part 2 (up to Day 98) ]
  11. Part 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: From start of study drug up to EOS in Part 2 (up to Day 98) ]
  12. Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [ Time Frame: From start of study drug up to EOS in Part 2 (up to Day 98) ]

Secondary Outcome Measures :
  1. Part 1: Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: From start of study drug up to EOS in Part 1 (Day 17) ]
  2. Part 1: Number of Participants Based on Severity of AEs [ Time Frame: From start of study drug up to EOS in Part 1 (Day 17) ]
  3. Part 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to EOS in Part 1 (Day 17) ]
  4. Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline up to EOS in Part 1 (Day 17) ]
  5. Part 1: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [ Time Frame: Baseline up to EOS in Part 1 (Day 17) ]
  6. Part 2: Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters [ Time Frame: From start of study drug up to Day 84 ]
  7. Part 2: Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 84 ]
  8. Part 2: Analysis of Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (24 hours) at Steady State (AUC0-tau) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 84 ]
  9. Part 2: Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 84 ]
  10. Part 2: Analysis of Apparent Terminal Elimination Half-life (t1/2) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters [ Time Frame: From start of study drug up to Day 84 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.
  2. Healthy overweight or obese adult men and women.
  3. Age greater then or equal to (>=)18 and less than or equal to (<=) 75 years.
  4. Body mass index (BMI) >=27.0 kilogram per square meter (kg/m^2).

Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06139055


Locations
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United States, Florida
ERG Clinical (Clinical Pharmacology of Miami - CPMI)
Miami, Florida, United States, 33014
Syneos Miami Site
Miami, Florida, United States, 33131
United States, Maryland
Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Gasherbrum Bio, Inc
More Information
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Responsible Party: Gasherbrum Bio, Inc
ClinicalTrials.gov Identifier: NCT06139055    
Other Study ID Numbers: GSBR-1290-05
First Posted: November 18, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
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.
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight