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NCT05333107 · ClinicalTrials.gov registry record · Phase 1

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

A Phase 1 study of Healthy Volunteers; High Cholesterol, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 1
Development phase
152
Enrollment target
2
Study locations

NCT05333107: Completed Phase 1 study of Healthy Volunteers; High Cholesterol, sponsored by Novo Nordisk A/S.

NCT05333107 is a Phase 1 study of Healthy Volunteers; High Cholesterol that has completed, run by Novo Nordisk A/S. The registered enrollment target is 152 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (153% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05333107, a Phase 1 study of Healthy Volunteers; High Cholesterol, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 1
Development phase
152 participants
Enrollment target
2
Study locations

Study Summary

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.

Primary Outcome

Measured in h \* nmol/L

Interventions

  • DRUG NNC0385-0434 G
  • DRUG NNC0385-0434 F
  • DRUG NNC0385-0434 B

Study Locations (2)

California

  • Altasciences - Cypress
  • Altasciences Clinical Los Angeles, Inc. - Los Angeles

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2022-04-12
Est. Completion 2022-09-23
Phase Phase 1
Novo Nordisk A/S

431 total trials

What the finished NCT05333107 record still lists

NCT05333107 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (153% higher).

The record links to 1 condition, with Healthy Volunteers; High Cholesterol appearing as the primary indexed condition, and to 3 interventions - of which NNC0385-0434 G is the first listed.

NCT05333107 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05333107 about?

NCT05333107 is a clinical study titled "A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II". In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided...

What is the current status of trial NCT05333107?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2022-04-12. Estimated completion is 2022-09-23.

What conditions does trial NCT05333107 study?

This clinical trial studies the following conditions: Healthy Volunteers; High Cholesterol.

What interventions are being tested in trial NCT05333107?

The interventions under investigation include: NNC0385-0434 G (DRUG), NNC0385-0434 F (DRUG), NNC0385-0434 B (DRUG).

Who is sponsoring clinical trial NCT05333107?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05333107 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05333107's enrollment target sits among peer trials

152 359th of 2000 higher than 1,638 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT05333107, the US trial registry maintained by the National Library of Medicine. NCT05333107 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.