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

NCT07221591 | Active Not Recruiting Phase 1

• 3 other identifiers: 1404-01032025-522325-35-00U1111-1322-4700
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  up to 232 days

• Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

  up to 232 days

Study Arms (2)

survodutide formulation A (reference treatment)

ACTIVE COMPARATOR

Combination Product: survodutide

survodutide formulation B2 (test treatment)

EXPERIMENTAL

Combination Product: survodutide

Interventions

survodutide COMBINATION_PRODUCT

survodutide, pre-filled syringe

survodutide formulation A (reference treatment); survodutide formulation B2 (test treatment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

CRS Clinical Research Services Berlin GmbH

Berlin, 13627, Germany

Location

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 28, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)