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NCT04880291 · ClinicalTrials.gov registry record · Phase 1

First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes

A Phase 1 study of Diabetes Mellitus and Kidney Diseases, sponsored by Goldfinch Bio.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target
1
Study location

NCT04880291: Completed Phase 1 study of Diabetes Mellitus and Kidney Diseases, sponsored by Goldfinch Bio.

NCT04880291 is a Phase 1 study of Diabetes Mellitus and Kidney Diseases that has completed, run by Goldfinch Bio. The registered enrollment target is 39 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04880291, a Phase 1 study of Diabetes Mellitus and Kidney Diseases, has completed, sponsored by Goldfinch Bio.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Number of participants with serious and other nonserious adverse events

Interventions

  • DRUG Placebo
  • DRUG GFB-024

Study Locations (1)

Texas

  • Worldwide Clinical Trials - San Antonio

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2021-05-05
Est. Completion 2022-02-08
Phase Phase 1
Goldfinch Bio

5 total trials

What the finished NCT04880291 record still lists

NCT04880291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (98% lower).

The record links to 5 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04880291 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT04880291 about?

NCT04880291 is a clinical study titled "First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes". 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 ...

What is the current status of trial NCT04880291?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2021-05-05. Estimated completion is 2022-02-08.

What conditions does trial NCT04880291 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Kidney Diseases, Diabetic Nephropathies, Endocrine System Diseases, Diabetes Complications.

What interventions are being tested in trial NCT04880291?

The interventions under investigation include: Placebo (DRUG), GFB-024 (DRUG).

Who is sponsoring clinical trial NCT04880291?

This trial is sponsored by Goldfinch Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04880291 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04880291's enrollment target sits among peer trials

39 168th of 208 higher than 41 of 208 other Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04880291, the US trial registry maintained by the National Library of Medicine. NCT04880291 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.