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A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis

NCT04004325 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-10-20

Study results available
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Summary

This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH.

The study may be conducted in up to 2 dosing cohorts.

Conditions

  • Nonalcoholic Steatohepatitis (NASH)
  • Overweight or Obesity

Interventions

DRUG

FT-4101

FT-4101 will be supplied as active capsules and will be administered per the protocol defined frequency and dose level.

DRUG

FT-4101 placebo

FT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level.

OTHER

Deuterated Water

Deuterated water will be provided as individual ready-to-use, single dose bottles each containing 50 mL of deuterated water (70%).

Sponsors & Collaborators

  • ProSciento, Inc.

    collaborator INDUSTRY

  • Forma Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Transparency (dept. 2834), MD · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-17
Primary Completion
2020-01-20
Completion
2020-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04004325 on ClinicalTrials.gov