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

Gasherbrum Bio

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: GSBR-1290; Drug: Placebo; Drug: Placebo (Capsule/Tablet); Drug: GSBR-1290 (Capsule/Tablet)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06139055

GSBR-1290-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 5 patient groups

Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 Tablet

Experimental group

Description:

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).

Treatment:

Drug: GSBR-1290 (Capsule/Tablet)

Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 Capsule

Experimental group

Description:

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).

Treatment:

Drug: GSBR-1290 (Capsule/Tablet)

Part 2 (Cohort 1): GSBR-1290/Placebo Tablet

Experimental group

Description:

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.

Treatment:

Drug: Placebo

Drug: GSBR-1290

Part 2 (Cohort 2): GSBR-1290/Placebo Tablet

Experimental group

Description:

Participants will receive GSBR-1290 or matching-placebo oral tablets once daily for a total of 12 weeks.

Treatment:

Drug: Placebo

Drug: GSBR-1290

Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo Capsule

Experimental group

Description:

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.

Treatment:

Drug: GSBR-1290 (Capsule/Tablet)

Drug: Placebo (Capsule/Tablet)