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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study drug up to eos in part 2 (up to day 98)
Awards & highlights

Study Summary

This trial tests if a new medicine is safe and effective in overweight/obese adults and how it is absorbed in the body.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study drug up to eos in part 2 (up to day 98)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study drug up to eos in part 2 (up to day 98) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
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
+9 more
Secondary outcome measures
Part 1: Number of Participants Based on Severity of AEs
Part 1: Number of Participants With Adverse Events (AEs) and Serious AEs
Part 1: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
+7 more

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 1
~20
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Gasherbrum Bio, IncLead Sponsor
2 Previous Clinical Trials
162 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research allow for my involvement?

"To be admitted into this research project, the participants must exhibit good health and lie within a specified age range of 18-75. This clinical trial is hoping to enrol around 70 individuals."

Answered by AI

To what extent is the population of participants being studied?

"Affirmative, the information available on clinicaltrials.gov states that this medical trial is actively enrolling patients. Initially posted on October 2nd 2023 and most recently updated November 14th 2023, this study requires 70 individuals to participate across 3 designated sites."

Answered by AI

Are new participants being welcomed to this experiment?

"Clinical trials.gov indicates that this medical trial is presently recruiting patients. It was first advertised on October 2nd 2023 and the information has since been refreshed on November 14th 2023."

Answered by AI

Are participants of this investigation limited to adults over 18 years old?

"This trial is available to adults between the ages of 18 and 75. However, there are separate trials for those under 18 years old, with 120 studies listed; as well as 644 medical research initiatives for people aged 65 or over."

Answered by AI

Has the FDA approved GSBR-1290 Capsule/GSBR-1290 Tablet as part of Sequence 1?

"This is a Phase 1 trial, so the safety of this medication (Sequence 1: Capsule to Tablet): GSBR-1290 Capsule/GSBR-1290 Tablet was rated as a one due to limited evidence in regards to efficacy and security."

Answered by AI

Who else is applying?

What site did they apply to?
ERG Clinical (Clinical Pharmacology of Miami - CPMI)
Syneos Miami Site
Parexel Baltimore Early Phase Clinical Unit
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants
2023. "A Study of Multiple-ascending Doses of GSBR-1290 in Healthy Overweight/Obese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139055.
~47 spots leftby Apr 2025
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