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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Part 1 is open-label, 2-period, 2-sequence, cross-over and Part 2 is double blinded

Study Groups

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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).

Group Type EXPERIMENTAL

GSBR-1290 (Capsule/Tablet)

Intervention Type DRUG

Participants will receive GSBR-1290 oral capsules or tablets.

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).

Group Type EXPERIMENTAL

GSBR-1290 (Capsule/Tablet)

Intervention Type DRUG

Participants will receive GSBR-1290 oral capsules or tablets.

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.

Group Type EXPERIMENTAL

GSBR-1290

Intervention Type DRUG

Participants will receive GSBR-1290 oral tablets.

Placebo

Intervention Type DRUG

Participants will receive matching-placebo oral tablets.

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.

Group Type EXPERIMENTAL

GSBR-1290

Intervention Type DRUG

Participants will receive GSBR-1290 oral tablets.

Placebo

Intervention Type DRUG

Participants will receive matching-placebo oral tablets.

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.

Group Type EXPERIMENTAL

GSBR-1290 (Capsule/Tablet)

Intervention Type DRUG

Participants will receive GSBR-1290 oral capsules or tablets.

Placebo (Capsule/Tablet)

Intervention Type DRUG

Participants will receive matching-placebo oral capsules or tablets.

Interventions

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GSBR-1290 (Capsule/Tablet)

Participants will receive GSBR-1290 oral capsules or tablets.

Intervention Type DRUG

GSBR-1290

Participants will receive GSBR-1290 oral tablets.

Intervention Type DRUG

Placebo

Participants will receive matching-placebo oral tablets.

Intervention Type DRUG

Placebo (Capsule/Tablet)

Participants will receive matching-placebo oral capsules or tablets.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes