NCT05090111

Brief Summary

A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

October 11, 2021

Last Update Submit

September 21, 2023

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (3)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

    Up to 14 days for Part 1

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

    Up to 28 days for Part 2

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

    Up to 35 days for Part 3

Secondary Outcomes (6)

  • Maximum Plasma Concentration [Cmax]

    Predose (between -0.25 hours and 0 hours) up to 35 Days

  • Area under the concentration time curve [AUC]

    Predose (between -0.25 hours and 0 hours) up to 35 Days

  • Time to maximum plasma concentration [Tmax]

    Predose (between -0.25 hours and 0 hours) up to 35 Days

  • Half-life [t1/2]

    Predose (between -0.25 hours and 0 hours) up to 35 Days

  • Minimum Plasma Concentration [Cmin]

    Predose (between -0.25 hours and 0 hours) up to 35 Days

  • +1 more secondary outcomes

Study Arms (2)

ALG-055009

EXPERIMENTAL

Oral dose(s) of ALG-055009 in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days

Drug: ALG-055009

Placebo

PLACEBO COMPARATOR

Oral dose(s) of placebo in Healthy Volunteer or subjects with mild hyperlipidemia once daily up to 14 days

Drug: Placebo

Interventions

ALG-055009DRUG

Single or multiple doses of ALG-055009

ALG-055009
PlaceboDRUG

Single or multiple doses of Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female between 18 and 55 years old
  • BMI 18.0 to 32.0 kg/m\^2
  • Male and Female between 18 and 65 years old
  • BMI 18.0 to 35.0 kg/m\^2
  • Subject must be on a stable diet for the 3 months prior to screening with a fasting LDL-C level \>110 mg/dL at screening

You may not qualify if:

  • Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
  • Subjects with Hepatitis A, B, C or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
  • Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
  • Subjects with history of thyroid disorder or abnormal thyroid function tests at screening or known sensitivity to thyroid medications
  • Subjects receiving, or urgently requiring, any lipid lowering therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotrial

Rennes, France

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

December 1, 2021

Primary Completion

June 16, 2023

Study Completion

June 16, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

FR(1)