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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05762471
Recruitment Status : Completed
First Posted : March 9, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
Gasherbrum Bio, Inc

Study Description
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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

Condition or disease Intervention/treatment Phase
Overweight or Obesity Type2 Diabetes Mellitus Drug: GSBR-1290 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
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
Official Title: 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
Actual Study Start Date : January 9, 2023
Actual Primary Completion Date : April 11, 2024
Actual Study Completion Date : April 11, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
 Drug: GSBR-1290
Patients will receive GSBR-1290 or matching Placebo

Drug: Placebo
Patients will receive GSBR-1290 or matching Placebo
Experimental: Cohort 2
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
 Drug: GSBR-1290
Patients will receive GSBR-1290 or matching Placebo

Drug: Placebo
Patients will receive GSBR-1290 or matching Placebo
Experimental: Cohort 3
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
 Drug: GSBR-1290
Patients will receive GSBR-1290 or matching Placebo

Drug: Placebo
Patients will receive GSBR-1290 or matching Placebo
Experimental: Cohort 4
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
 Drug: GSBR-1290
Patients will receive GSBR-1290 or matching Placebo

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

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


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 42 days ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 and women with T2DM of ≥6 months duration
  2. Age ≥ 18 and ≤ 75 years
  3. BMI ≥ 27 and ≤ 40 kg/m2
  4. 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:

  1. 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
  2. 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.
  3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
  4. 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
  5. Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area
  6. Known hypersensitivity to any of the study drug ingredients
  7. Any other condition or prior therapy that would make the participant unsuitable for this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05762471


Locations
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United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
ProSciento, Inc
Chula Vista, California, United States, 91911
United States, Florida
QPS Miami Research Associates
Miami, Florida, United States, 33143
Progressive Medical Research
Port Orange, Florida, United States, 32127
Sponsors and Collaborators
Gasherbrum Bio, Inc
More Information
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Responsible Party: Gasherbrum Bio, Inc
ClinicalTrials.gov Identifier: NCT05762471    
Other Study ID Numbers: GSBR-1290-02
First Posted: March 9, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight