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A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body

NCT ID: NCT07221591

Last Updated: 2025-12-24

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-08-24

Brief Summary

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This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2.

The purpose of this study is to test a new formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body.

Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation of survodutide (formulation B2). Participants in both groups inject survodutide under their skin once a week for about 6 and a half months.

Participants are in the study for about 7 months. During this time, they visit the study site 15 times. For one of the visits, participants stay overnight for 3 nights at the study site. The site staff takes blood samples to measure how much survodutide is in the blood. They also check participants' health and take note of any unwanted effects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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survodutide formulation A (reference treatment)

Group Type ACTIVE_COMPARATOR

survodutide

Intervention Type DRUG

survodutide

survodutide formulation B2 (test treatment)

Group Type EXPERIMENTAL

survodutide

Intervention Type DRUG

survodutide

Interventions

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survodutide

survodutide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 65 years (inclusive)
* Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive)

Exclusion Criteria

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 100 mmHg, or pulse rate outside the range of 50 to 100 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Presence of hypertension, hypothyroidism, hyperuricaemia and hypercholesterolaemia are acceptable if well-controlled according to the investigator's judgement.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

CRS Clinical Research Services Mannheim GmbH

Mannheim, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2025-522325-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

U1111-1322-4700

Identifier Type: REGISTRY

Identifier Source: secondary_id

1404-0103

Identifier Type: -

Identifier Source: org_study_id