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

NCT ID: NCT05409924

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2023-10-04

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Phase A

ATR-258 Single Ascending Dose or placebo

Group Type EXPERIMENTAL

ATR-258

Intervention Type DRUG

Single Ascending Dose

Phase B

ATR-258 Multiple Ascending Dose or placebo

Group Type EXPERIMENTAL

ATR-258

Intervention Type DRUG

Multiple Ascending Dose

Phase C

ATR-258 Repeated dosing or placebo

Group Type EXPERIMENTAL

ATR-258

Intervention Type DRUG

Repeat Dose

Interventions

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ATR-258

Single Ascending Dose

Intervention Type DRUG

ATR-258

Multiple Ascending Dose

Intervention Type DRUG

ATR-258

Repeat Dose

Intervention Type DRUG

Other Intervention Names

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Placebo Placebo Placebo

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* Type 1 diabetes mellitus (T1DM) or ketosis-prone T2D based on diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Key2Compliance

INDUSTRY

Sponsor Role collaborator

CRS Clinical Research Services Mannheim GmbH

INDUSTRY

Sponsor Role collaborator

Atrogi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CRS Clinical Research Services

Mannheim, , Germany

Site Status

Countries

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Germany

Related Links

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https://atrogi.com/

Related Info

Other Identifiers

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ATR-258-study-1

Identifier Type: -

Identifier Source: org_study_id