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

Type2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762471
• Other study ID #: GSBR-1290-02
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 9, 2023
• Est. completion date: April 11, 2024

Study information

• Verified date: April 2024
• Source: Gasherbrum Bio, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Overweight or Obesity
• Type2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	ProSciento, Inc	Chula Vista	California
United States	QPS Miami Research Associates	Miami	Florida
United States	Progressive Medical Research	Port Orange	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gasherbrum Bio, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters		31 days
Secondary	Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters		31 days
Secondary	Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters		31 days
Secondary	Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma		31 days