NCT05762471

Brief Summary

This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV) and Type 2 Diabetes Mellitus on Metformin (T2DM) This study includes 5 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 84

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

January 25, 2023

Last Update Submit

April 24, 2024

Conditions

Overweight or ObesityType2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma

    31 days

Study Arms (5)

Cohort 1

EXPERIMENTAL

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Drug: GSBR-1290Drug: Placebo

Cohort 2

EXPERIMENTAL

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Drug: GSBR-1290Drug: Placebo

Cohort 3

EXPERIMENTAL

Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks

Drug: GSBR-1290Drug: Placebo

Cohort 4

EXPERIMENTAL

HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks

Drug: GSBR-1290Drug: Placebo

Cohort 5

EXPERIMENTAL

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

Drug: GSBR-1290Drug: Placebo

Interventions

GSBR-1290DRUG

Patients will receive GSBR-1290 or matching Placebo

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG

Patients will receive GSBR-1290 or matching Placebo

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provided evidence of a signed consent
  • Age ≥ 18 and ≤ 75 years
  • Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2
  • No nicotine use
  • Have a suitable venous access for blood sampling
  • Men and women with T2DM of ≥6 months duration
  • Age ≥ 18 and ≤ 75 years
  • BMI ≥ 27 and ≤ 40 kg/m2
  • 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%.

You may not qualify if:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months
  • A sitting BP after resting for 5 minutes \> 160mm Hg systolic or \> 100 mm Hg diastolic or an apical pulse rate \<50 or \>100 beats per minute.
  • Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
  • Liver function test results elevated \> 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
  • Estimated glomerular filtration rate \< 60mL/min/1.73 m2 body surface area
  • Known hypersensitivity to any of the study drug ingredients
  • Any other condition or prior therapy that would make the participant unsuitable for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

ProSciento, Inc

Chula Vista, California, 91911, United States

Location

QPS Miami Research Associates

Miami, Florida, 33143, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
This is a double-blind study in which the GSBR-1290 and the matching placebo are matching in appearance
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

March 9, 2023

Study Start

January 9, 2023

Primary Completion

April 11, 2024

Study Completion

April 11, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Shared Documents
STUDY PROTOCOL
Time Frame
Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product have been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes: * re-evaluating safety and efficacy end points already addressed in the product labelling, * assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

Locations

US(4)