First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
Completed · Phase 1 · Has a placebo group
Conditions studied: Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
In brief
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
Key facts
- Study ID
- NCT04880291
- Run by
- Goldfinch Bio, Inc.
- People needed
- 39
- Starts
- 2021-05-05
- Expected to finish
- 2022-02-08
- Last updated by the study team
- 2022-03-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 to 75 years of age at the time of signing informed consent.
- Body mass index (BMI) between 25.0 and 40.0 kg/m2, inclusive, at Screening.
- Female participants will be of non-childbearing potential.
- Male participants will agree to use contraception while on study intervention and for at least 6 months after the last dose of study intervention.
- SAD cohorts only: Participants must be in good health.
- Repeat-dose cohort only: Type 2 diabetes mellitus (T2DM) treated with lifestyle modification or metformin, and in otherwise good health except for well-controlled common conditions associated with T2DM, such as hypertension and dyslipidemia.
You may not qualify if…
- History of, or treatment for, psychiatric illness, including anxiety or depression within 5 years of the Screening visit.
- Participants with a history of attempted suicide or clinically significant suicidal ideation.
- History of cardiovascular disease.
- Blood pressure >155 mmHg systolic or >95 mmHg diastolic.
- History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
- Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
- History of significant hypersensitivity, intolerance, or allergy to more than one class of drugs.
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
- SAD cohorts only: Fasting glucose >126 mg/dL.
Where it is running
- Worldwide Clinical Trials — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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