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GSBR-1290

Phase 1

Overweight or Obesity | Small molecule | Metabolic |Structure Therapeutics Inc.|Trials Updated: Apr 25, 2024

GSBR-1290 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Mar 2023

GSBR-1290 target and mechanism

Molecular targetGLP-1 receptor
Target classGpcr
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

GSBR-1290 clinical trials

GSBR-1290 · 1 trial · 2 indications

Phase 1 1
NCT05762471Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes MellitusOverweight or Obesity
COMPLETED142 Analytics
PHASE1COMPLETED
Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Overweight or ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

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
42 days

Secondary Endpoints

Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
31 days
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
31 days
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
31 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALPatients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 2EXPERIMENTALPatients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 3EXPERIMENTALPatients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Cohort 4EXPERIMENTALHOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Cohort 5EXPERIMENTALParticipants 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

Interventions

NameTypeDescription
GSBR-1290DRUGPatients will receive GSBR-1290 or matching Placebo
PlaceboDRUGPatients will receive GSBR-1290 or matching Placebo
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria cohorts 1-4: 1. Provided evidence of a signed consent 2. Age ≥ 18 and ≤ 75 years 3. Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 4. No nicotine use 5. Have a suitable venous access for blood sampling Inclusion Criteria cohort 5: 1. Men a...

Countries:United States
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Frequently asked questions about GSBR-1290

What is GSBR-1290 used for?

GSBR-1290 is being developed for the treatment of overweight or obesity. It is also being studied in people with type 2 diabetes mellitus. It is an investigational small molecule and has not been approved for any indication.

What does GSBR-1290 target?

GSBR-1290 targets the GLP-1 receptor, a G protein-coupled receptor (GPCR). By acting on this receptor, it is designed to mimic the effects of the natural incretin hormone GLP-1, which is involved in appetite regulation and glucose metabolism.

Who is developing GSBR-1290?

GSBR-1290 is being developed by Structure Therapeutics Inc., which trades on the Nasdaq under the ticker GPCR. The company is responsible for the clinical development of the drug.

What phase is GSBR-1290 in?

GSBR-1290 is in Phase 1 clinical development. It has completed one Phase 1b/2a trial. It is an investigational drug and has not been approved by the FDA or any other regulatory agency.

What clinical trials is GSBR-1290 in?

GSBR-1290 has been evaluated in a single clinical trial, NCT05762471, titled "Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus." This completed trial enrolled 142 participants in the United States.