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Completed

NCT Number: NCT05409924

First-in-human Single and Multiple Dose Trial of ATR-258

This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.

Completed

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services

Mannheim, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Phase A and B:

  • Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Body mass index (BMI) within the range 18.5 - 29.9 kg/m2 (inclusive) at screening.
  • Male

Inclusion criteria

Phase C:

  • Participant must be 30 to 75 years of age inclusive, at the time of signing the informed consent.
  • BMI within the range 25.0 to 45.0 kg/m2 and body weight from 80 to 160 kg (inclusive) at screening.
  • Male

Exclusion criteria

Phase C:

  • Type 1 diabetes mellitus (T1DM) or ketosis-prone T2D based on diagnosis

Treatment and study plan

ATR-258

Drug

Single Ascending Dose

Other names: Placebo

Primary outcomes

  1. Safety analyses after single dose of ATR-258

    Time frame: maximum 7 days post dosing

    Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258

  2. Safety analyses after multiple doses of ATR-258

    Time frame: maximum 56 days post dosing

    Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258

Secondary outcomes

  1. PK analyses will be performed after PK of ATR-258 single dose

    Time frame: maximum 7 days post dosing

    PK analyses will be performed based on AUC0-inf of ATR-258 in plasma

  2. PK analyses will be performed after PK of ATR-258 single dose

    Time frame: maximum 7 days post dosing

    PK analyses will be performed based on AUC0-tz of ATR-258 in plasma

  3. PK analyses will be performed after PK of ATR-258 single dose

    Time frame: maximum 7 days post dosing

    PK analyses will be performed based on Cmax of ATR-258 in plasma

  4. PK analyses will be performed after PK of ATR-258 multiple dose

    Time frame: maximum 56 days post dosing

    PK analyses will be performed based on AUCtau of ATR-258 in plasma

  5. PK analyses will be performed after PK of ATR-258 multiple dose

    Time frame: maximum 56 days post dosing

    PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma

  6. PK analyses will be performed after PK of ATR-258 multiple dose

    Time frame: maximum 56 days post dosing

    PK analyses will be performed based on Cmax,MD of ATR-258 in plasma

Sponsors and collaborators

Lead sponsor

Atrogi AB

Industry

Collaborators

  • CRS Clinical Research Services Mannheim GmbH
  • Key2Compliance

Registry information

Official study title

The ATTRACTIVE 1 Trial - a First-in-human Phase I, Dose Escalating, Double-blind, Placebo-controlled, Single and Multiple Dose Trial of ATR-258 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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