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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409924
• Other study ID #: ATR-258-study-1
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2022
• Est. completion date: October 4, 2023

Study information

• Verified date: December 2023
• Source: Atrogi AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 4, 2023
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ATR-258
Single Ascending Dose
• ATR-258
Multiple Ascending Dose
• ATR-258
Repeat Dose

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services	Mannheim

Sponsors (3)

Lead Sponsor	Collaborator
Atrogi AB	CRS Clinical Research Services, Key2Compliance

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety analyses after single dose of ATR-258	Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258	maximum 7 days post dosing
Primary	Safety analyses after multiple doses of ATR-258	Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258	maximum 56 days post dosing
Secondary	PK analyses will be performed after PK of ATR-258 single dose	PK analyses will be performed based on AUC0-inf of ATR-258 in plasma	maximum 7 days post dosing
Secondary	PK analyses will be performed after PK of ATR-258 single dose	PK analyses will be performed based on AUC0-tz of ATR-258 in plasma	maximum 7 days post dosing
Secondary	PK analyses will be performed after PK of ATR-258 single dose	PK analyses will be performed based on Cmax of ATR-258 in plasma	maximum 7 days post dosing
Secondary	PK analyses will be performed after PK of ATR-258 multiple dose	PK analyses will be performed based on AUCtau of ATR-258 in plasma	maximum 56 days post dosing
Secondary	PK analyses will be performed after PK of ATR-258 multiple dose	PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma	maximum 56 days post dosing
Secondary	PK analyses will be performed after PK of ATR-258 multiple dose	PK analyses will be performed based on Cmax,MD of ATR-258 in plasma	maximum 56 days post dosing

External Links

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