Type 2 Diabetes MellitusPhase 1NCT05409924

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

A Phase 1 study testing ATR-258 in people with Type 2 Diabetes Mellitus, run by Atrogi AB at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: ATR-258
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteGermany
Study dates: 11 Apr 2022to 4 Oct 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services
Mannheim

Other trials in Germany

About this study

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

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

Conditions: Type 2 Diabetes Mellitus
Being tested: ATR-258
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ATR-258Drug
Also called Placebo
Single Ascending Dose
ATR-258Drug
Also called Placebo
Multiple Ascending Dose
ATR-258Drug
Also called Placebo
Repeat Dose

Study groups in NCT05409924
Study group	Role	What they receive
Phase A	Experimental	ATR-258 Single Ascending Dose or placebo Receives: Drug: ATR-258
Phase B	Experimental	ATR-258 Multiple Ascending Dose or placebo Receives: Drug: ATR-258
Phase C	Experimental	ATR-258 Repeated dosing or placebo Receives: Drug: ATR-258

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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
Measured: maximum 7 days post dosing
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
Measured: maximum 7 days post dosing
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
Measured: maximum 7 days post dosing
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
Measured: maximum 56 days post dosing
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
Measured: maximum 56 days post dosing
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
Measured: maximum 56 days post dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 20224 Oct 2023

First posted8 Jun 2022
Study start11 Apr 2022
Primary completion4 Oct 2023
Study completion4 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05409924
Sponsor's protocol ID: ATR-258-study-1
Status last verified: Dec 2023
First submitted: 13 May 2022
Last updated: 18 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05409924
Acronym / sponsor ID: ATR-258-study-1
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Atrogi ABIndustry (pharma, biotech, devices)
Collaborators: Key2Compliance, CRS Clinical Research Services Mannheim GmbH
Study start: 11 Apr 2022 (actual)
Primary completion: 4 Oct 2023 (actual)
Study completion: 4 Oct 2023 (actual)
First posted: 8 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Phase A	Experimental	Drug: ATR-258ATR-258 Single Ascending Dose or placebo
Phase B	Experimental	Drug: ATR-258ATR-258 Multiple Ascending Dose or placebo
Phase C	Experimental	Drug: ATR-258ATR-258 Repeated dosing or placebo

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ATR-258Also: PlaceboSingle Ascending Dose	Drug	Phase A
ATR-258Also: PlaceboMultiple Ascending Dose	Drug	Phase B
ATR-258Also: PlaceboRepeat Dose	Drug	Phase C

Primary outcome

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
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

6 secondary outcomes

PK analyses will be performed after PK of ATR-258 single dose
Time frame: maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 single dose
Time frame: maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 single dose
Time frame: maximum 7 days post dosing
PK analyses will be performed after PK of ATR-258 multiple dose
Time frame: maximum 56 days post dosing
PK analyses will be performed after PK of ATR-258 multiple dose
Time frame: maximum 56 days post dosing
PK analyses will be performed after PK of ATR-258 multiple dose
Time frame: maximum 56 days post dosing

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Related InfoLink provided by the sponsor.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATR-258 in people with Type 2 Diabetes Mellitus, run by Atrogi AB at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety analyses after single dose of ATR-258 (time frame: maximum 7 days post dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05409924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.