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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05409924

Enrollment

Registered

2022-06-08

Start date

2022-04-11

Completion date

2023-10-04

Last updated

2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

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

Interventions

DRUGATR-258

Single Ascending Dose

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety analyses after single dose of ATR-258	maximum 7 days post dosing	Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258
Safety analyses after multiple doses of ATR-258	maximum 56 days post dosing	Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258

Secondary

Measure	Time frame	Description
PK analyses will be performed after PK of ATR-258 single dose	maximum 7 days post dosing	PK analyses will be performed based on AUC0-inf of ATR-258 in plasma
PK analyses will be performed after PK of ATR-258 multiple dose	maximum 56 days post dosing	PK analyses will be performed based on AUCtau of ATR-258 in plasma

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 7, 2026