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

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ClinicalTrials.gov Identifier: NCT06139055

Recruitment Status : Active, not recruiting

First Posted : November 18, 2023

Last Update Posted : February 15, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Gasherbrum Bio, Inc

Tracking Information

First Submitted Date ^ICMJE

November 14, 2023

First Posted Date ^ICMJE

November 18, 2023

Last Update Posted Date

February 15, 2024

Actual Study Start Date ^ICMJE

October 2, 2023

Estimated Primary Completion Date

March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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) ]
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) ]
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) ]
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) ]
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) ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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) ]
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) ]
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) ]
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) ]
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) ]
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 ]
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 ]
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 ]
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 ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: GSBR-1290 (Capsule/Tablet)
Participants will receive GSBR-1290 oral capsules or tablets.
Drug: GSBR-1290
Participants will receive GSBR-1290 oral tablets.
Drug: Placebo
Participants will receive matching-placebo oral tablets.
Drug: Placebo (Capsule/Tablet)
Participants will receive matching-placebo oral capsules or tablets.

Study Arms ^ICMJE

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).

Intervention: Drug: GSBR-1290 (Capsule/Tablet)
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).

Intervention: Drug: GSBR-1290 (Capsule/Tablet)
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.
Interventions:
- Drug: GSBR-1290
- Drug: Placebo
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.
Interventions:
- Drug: GSBR-1290
- Drug: Placebo
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.
Interventions:
- Drug: GSBR-1290 (Capsule/Tablet)
- Drug: Placebo (Capsule/Tablet)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Actual Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

March 2024

Estimated Primary Completion Date

March 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Provided evidence of a signed informed consent before any study-related activities are initiated and be willing to comply with all study procedures.
Healthy overweight or obese adult men and women.
Age greater then or equal to (>=)18 and less than or equal to (<=) 75 years.
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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT06139055

Other Study ID Numbers ^ICMJE

GSBR-1290-05

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

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.