Current partner codePEPTIDESDE
NCT03591718·Phase 1·INTERVENTIONAL

A Study to Test Different Doses of BI 456906 in Patients With Obesity

Status

Completed

Phase

Phase 1

Enrollment

131

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.

Interventions

Treatment arms and agents.

DRUG

BI 456906

Solution for injection

DRUG

Placebo

solution for injection

Timeline

From registration to results.

  1. First posted

    Jul 19, 2018

  2. Study start

    Jul 26, 2018

  3. Primary completion

    Apr 20, 2020

  4. Study completion

    Apr 30, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Mar 22, 2021

Outcomes

What the study measures.

Primary outcomes

Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme

Time frame · Up to 132 days

Secondary outcomes

AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)

Time frame · Up to 168 hours

Cmax (maximum measured concentration of the analyte in plasma) after first dose

Time frame · Up to 132 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Male and female patients ≥ 18 years and \< 70 years of age at screening * Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening * A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening * HbA1c \<6.5% * Further inclusion criteria apply Exclusion Criteria: * Women who are pregnant, nursing, or who plan to become pregnant while in the trial * Supine blood pressure (BP) ≥160/100 mmHg at screening * Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Further exclusion criteria apply

Study locations

2 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Profil Mainz GmbH & Co. KG

Mainz, Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

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