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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05762471

Enrollment

142

Registered

2023-03-09

Start date

2023-01-09

Completion date

2024-04-11

Last updated

2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or Obesity, Type2 Diabetes Mellitus

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

Interventions

DRUGGSBR-1290

Patients will receive GSBR-1290 or matching Placebo

DRUGPlacebo

Patients will receive GSBR-1290 or matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026