What side effects are associated with this type of intervention?

Common side effects for treatments in healthy overweight/obese participants or similar metabolic conditions often include gastrointestinal issues such as nausea and diarrhea, as seen with bromocriptine-QR and GSK2330672. Headaches are also frequently reported. These side effects are generally mild to moderate in severity.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects are relatively rare, as most approvals focus on specific conditions or diseases. However, drugs studied in healthy populations often include those for weight management and metabolic health, such as orlistat for weight loss. These treatments are typically evaluated for safety and efficacy in healthy individuals before broader approval.

What other types of research exist?

Promising novel alternatives to GSBR-1290 for healthy subjects considering treatment in 2024 include semaglutide and tirzepatide. Semaglutide, a GLP-1 receptor agonist, has shown significant efficacy in weight management. Tirzepatide, a dual GIP and GLP-1 receptor agonist, has also demonstrated substantial weight loss benefits in clinical trials. Both agents have been well-tolerated and are considered effective options for managing overweight and obesity.

← Back to Search

Other

GSBR-1290 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Gasherbrum Bio, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 and less than or equal to 75 years.

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new medication called GSBR-1290 in tablet and capsule forms on healthy overweight/obese individuals. It aims to see how the body processes the drug and compares the effectiveness of different forms.

Who is the study for?

This clinical trial is for healthy adult men and women who are overweight or obese, aged between 18 to 75 years old with a BMI of at least 27.0 kg/m^2. Participants must understand the study procedures and agree to follow them by signing an informed consent form.

What is being tested?

The trial is testing GSBR-1290, a new medication in capsule/tablet form, against a placebo (a pill with no active drug) to assess its safety and how it's processed by the body when given repeatedly to healthy overweight/obese individuals.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include digestive discomfort, headaches, fatigue or allergic reactions. The study aims to determine the tolerability of GSBR-1290 so participants will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a significant health condition affecting my heart, lungs, liver, kidneys, blood, stomach, hormones, immune system, skin, or nerves.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2 (Cohort 3): GSBR-1290/Placebo Tablet and GSBR-1290/Placebo CapsuleExperimental Treatment2 Interventions

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 II: Part 2 (Cohort 2): GSBR-1290/Placebo TabletExperimental Treatment2 Interventions

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

Group III: Part 2 (Cohort 1): GSBR-1290/Placebo TabletExperimental Treatment2 Interventions

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

Group IV: Part 1(Sequence 2: Tablet to Capsule): GSBR-1290 Tablet/GSBR-1290 CapsuleExperimental Treatment1 Intervention

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 V: Part 1 (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 TabletExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

GSBR-1290

2023

Completed Phase 2

~160

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for healthy subjects, particularly those targeting metabolic health and weight management, often involve mechanisms such as appetite suppression, increased energy expenditure, and improved insulin sensitivity. These treatments may include GLP-1 receptor agonists, which enhance insulin secretion and slow gastric emptying, or SGLT2 inhibitors, which reduce glucose reabsorption in the kidneys. Understanding these mechanisms is crucial for healthy subjects as it helps in selecting appropriate interventions that can safely and effectively manage weight and metabolic parameters, thereby reducing the risk of developing chronic conditions like diabetes and cardiovascular diseases.

Fluoroquinolones in the management of tuberculous meningitis: Systematic review and meta-analysis.Potential role of phytochemicals in metabolic syndrome prevention and therapy.Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update.