Clinical trial NCT05762471: Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight or Obesity
Type2 Diabetes Mellitus
Lead sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-03-09
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 42 days
Secondary outcomes:
measure: Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters
timeFrame: 31 days
measure: Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters
timeFrame: 31 days
measure: Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters
timeFrame: 31 days
measure: Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma
timeFrame: 31 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Chula Vista
country: United States
facility: ProSciento, Inc
state: California
city: Miami
country: United States
facility: QPS Miami Research Associates
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
Study officials:
References: