Cohort 2 for Obesity

Anaheim Clinical Trials, Anaheim, CA
ObesityGSBR-1290 - Drug
Eligibility
18 - 75
All Sexes

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.

Eligible Conditions
  • Overweight or Obesity

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 42 days

31 days
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
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma
42 days
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

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

3 Treatment Groups

Cohort 2
1 of 3
Cohort 3
1 of 3
Cohort 1
1 of 3

Experimental Treatment

24 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort 2 · Has Placebo Group · Phase 1

Cohort 2Experimental Group · 2 Interventions: GSBR-1290, Placebo · Intervention Types: Drug, Drug
Cohort 3Experimental Group · 2 Interventions: GSBR-1290, Placebo · Intervention Types: Drug, Drug
Cohort 1Experimental Group · 2 Interventions: GSBR-1290, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 42 days

Who is running the clinical trial?

Gasherbrum Bio, IncLead Sponsor

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You do not use any nicotine products.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Does this experiment encompass geriatric patients?

"This clinical trial is enrolling individuals aged 18 to 75." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.