Current partner codePEPTIDESDE
NCT07221591·Phase 1·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 1

Enrollment

100

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

survodutide

survodutide, pre-filled syringe

Timeline

From registration to results.

  1. First posted

    Oct 28, 2025

  2. Study start

    Nov 5, 2025

  3. Primary completion

    Aug 4, 2026

  4. Study completion

    Aug 4, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Mar 13, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · up to 232 days

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

Time frame · up to 232 days

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

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) * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply. 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. Further exclusion criteria apply.

Study locations

2 registered sites.

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

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

CRS Clinical Research Services Mannheim GmbH

Mannheim, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.