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GSBR-1290 for Obesity and Type 2 Diabetes
Phase 1 & 2
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
Cohorts 1-4: Age ≥ 18 and ≤ 75 years
Cohort 5: Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights
Study Summary
This trial will test a new drug's safety and effects on overweight/obese volunteers. It will involve multiple doses of the drug or placebo over 28 days.
Who is the study for?
This trial is for adults aged 18-75 who are overweight or obese with a BMI of 27-40 kg/m2, and those with Type 2 Diabetes Mellitus on stable metformin treatment. Participants should not use nicotine, have good venous access for blood sampling, and no significant health issues like heart or kidney disease.Check my eligibility
What is being tested?
The study tests GSBR-1290's safety and effects compared to a placebo in overweight/obese individuals and those with Type 2 Diabetes over three months. It will look at how the body processes the drug (PK) and its impact on the body (PD).See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to drug ingredients, impacts on organ function as indicated by exclusion criteria such as liver test abnormalities, cardiovascular issues detected by ECG changes, or other systemic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I have been on a stable dose of metformin (≥500 mg) for at least 6 months, with my HbA1c between 7.0% and 10.5%.
Select...
I am between 18 and 75 years old.
Select...
I am an adult with a BMI between 27 and 40.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM
Secondary outcome measures
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks
Group II: Cohort 4Experimental Treatment2 Interventions
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Group III: Cohort 3Experimental Treatment2 Interventions
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Group IV: Cohort 2Experimental Treatment2 Interventions
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Group V: Cohort 1Experimental Treatment2 Interventions
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
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
Who is running the clinical trial?
Gasherbrum Bio, IncLead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 27 and 40.I have a history of heart rhythm problems or abnormal ECG results.My blood pressure is high or my heart rate is too low or too high after resting.My liver tests are more than twice the normal limit.I have not had any major illnesses or surgeries in the last 3 months.I am between 18 and 75 years old.You cannot use any nicotine products if you are in Cohorts 1-4.I have had type 2 diabetes for at least 6 months.I have been on a stable dose of metformin (≥500 mg) for at least 6 months, with my HbA1c between 7.0% and 10.5%.I am between 18 and 75 years old.You don't use any nicotine products.I do not have any health issues that would prevent me from joining this study.My kidney function is reduced.I am an adult with a BMI between 27 and 40.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 4
- Group 5: Cohort 5
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could Cohort 1 be deleterious to individuals?
"As this is an early stage trial, limited data is available to anticipate the safety and efficacy of Cohort 1. Consequently, it was given a score of 1 out of 3 by Power researchers."
Answered by AI
Does this experiment encompass geriatric patients?
"This clinical trial is enrolling individuals aged 18 to 75."
Answered by AI
Which patient types are being considered for enrollment in this clinical study?
"To qualify for this trial, individuals must be aged 18 to 75 and have a BMI that classifies them as overweight or obese. 24 participants are needed in total."
Answered by AI
How many healthcare centers are conducting this experiment?
"Four unique medical centres are enrolling patients for this trial: ProSciento, Inc in Chula Vista; QPS Miami Research Associates in Miami; Progressive Medical Research in Port Orange and additional medical sites."
Answered by AI
Is enrolment still open for this research project?
"Affirmative. The information hosted on clinicaltrials.gov indicates that this experiment is currently recruiting volunteers, with 24 individuals needed from 4 locations. This research was first published on the 9th of January 2023 and has been edited as recently as 28th February 2023"
Answered by AI
How many participants are included in the cohort of this clinical experiment?
"Affirmative, clinicaltrials.gov records reveal that recruitment is ongoing for this investigation which was published on the 9th of January 2023 and has since been amended on the 28th of February in the same year. 24 volunteers are needed across 4 medical centres."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
ProSciento, Inc
Anaheim Clinical Trials
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I hope it helps me. I am looking to eliminate diabetes. Always looking to improve my health care. 24 years a diabetic 2 hoping to learn some changes that work!
PatientReceived 1 prior treatment
I am an obese person. I've tried different approaches to lose weight and no positive results to date. I hope that a treatment involving medication from a clinical trial can help me while I can help others in the future.
PatientReceived 1 prior treatment
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