Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT05762471

Recruitment Status : Completed

First Posted : March 9, 2023

Last Update Posted : April 25, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Gasherbrum Bio, Inc

Tracking Information

First Submitted Date ^ICMJE

January 25, 2023

First Posted Date ^ICMJE

March 9, 2023

Last Update Posted Date

April 25, 2024

Actual Study Start Date ^ICMJE

January 9, 2023

Actual Primary Completion Date

April 11, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 42 days ]

Original Primary Outcome Measures ^ICMJE

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 [ Time Frame: 42 days ]

Change History

Current Secondary Outcome Measures ^ICMJE

Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters [ Time Frame: 31 days ]
Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters [ Time Frame: 31 days ]
Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters [ Time Frame: 31 days ]
Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma [ Time Frame: 31 days ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

Official Title ^ICMJE

A Phase 1b/2a, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus on Metformin

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

This is a double-blind study in which the GSBR-1290 and the matching placebo are matching in appearance

Primary Purpose: Treatment

Condition ^ICMJE

Overweight or Obesity
Type2 Diabetes Mellitus

Intervention ^ICMJE

Drug: GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Drug: Placebo
Patients will receive GSBR-1290 or matching Placebo

Study Arms ^ICMJE

Experimental: Cohort 1
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Interventions:
- Drug: GSBR-1290
- Drug: Placebo
Experimental: Cohort 2
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Interventions:
- Drug: GSBR-1290
- Drug: Placebo
Experimental: Cohort 3
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Interventions:
- Drug: GSBR-1290
- Drug: Placebo
Experimental: Cohort 4
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
Interventions:
- Drug: GSBR-1290
- Drug: Placebo
Experimental: Cohort 5
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
Interventions:
- Drug: GSBR-1290
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

142

Original Estimated Enrollment ^ICMJE

Actual Study Completion Date ^ICMJE

April 11, 2024

Actual Primary Completion Date

April 11, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria cohorts 1-4:

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

Inclusion Criteria cohort 5:

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%.

Exclusion Criteria:

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05762471

Other Study ID Numbers ^ICMJE

GSBR-1290-02

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Plan Description:	De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials:	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.