First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
NCT ID: NCT04880291
Last Updated: 2022-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2021-05-05
2022-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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GFB-024 SAD Active
Single ascending dose arm of GFB-024 treatment
GFB-024
Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
SAD Placebo
Single ascending dose arm of placebo treatment
Placebo
Matched placebo
GFB-024 Repeat-dose Active
Repeat-dose arm of GFB-024 treatment
GFB-024
Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
Repeat-dose Placebo
Repeat-dose arm of placebo treatment
Placebo
Matched placebo
Interventions
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GFB-024
Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
Placebo
Matched placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Goldfinch Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ingela Danielsson, MD, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
Worldwide Clinical Trails
Locations
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Worldwide Clinical Trials
San Antonio, Texas, United States
Countries
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Other Identifiers
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GFB-024-102
Identifier Type: -
Identifier Source: org_study_id
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