CompletedPhase 1

A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body

Safety, Tolerability and Pharmacokinetics Study of Multiple Rising Subcutaneous Doses of Survodutide in Chinese Participants With Overweight or Obesity (BMI 24.0 to 40.0 kg/m2) (Non-randomization, Open Label, Parallel Group Design)

Lead sponsor

Boehringer Ingelheim

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30•Healthy volunteers

Primary endpoints

•AUC0-168•Cmax after the first dose•Cmax after multiple doses

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06492135

Org study ID1404-0013

Timeline

Milestones

Study first posted2024-07-09actual

Study start2024-08-12actual

Primary completion2025-04-15actual

Study completion2025-04-15actual

Last update posted2025-04-23actual

Assets

Investigational agents

Survodutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Chinese ethnicity

•Age of 18 to 60 years

•40≥ body mass index (BMI) ≥30 kilogram (kg)/ square meters (m²) at screening, or 30> BMI ≥27 kg/m² at screening with the presence of at least one of the following weight-related complications

-Hypertension

-Dyslipidemia

-Obstructive sleep apnea

-Cardiovascular disease (CVD) (e.g. heart failure (HF) with New York Heart Association (NYHA) functional class II-III, history of ischemic or hemorrhagic stroke or cerebrovascular revascularization procedure [e.g. carotid endarterectomy and/or stent], myocardial infarction (MI), coronary artery disease, or peripheral vascular disease)

-Non-alcoholic steato hepatitis (NASH), as assessed in medical records by histological liver assessment (within the last 6 months) or overweight but otherwise healthy participants with BMI ≥ 24 but < 27 kg/m² according to the assessment of the investigator, based on a complete medical history, physical examination, vital signs (BP, PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening.

•stable body weight in the 3 months prior to screening visit (defined as no more than 5% change by self-report)

•further inclusion criteria apply

Exclusion criteria

•Repeated measurement of sitting blood pressure (BP) ≥160/95 millimeter of mercury (mmHg), or pulse rate (PR) >100 beats per minute (bpm) after 5 minutes of resting at screening visit.

•Exposure to any glucagon-like-peptide 1 receptor (GLP-1R) agonist (including combination products) within three months prior to screening visit, or any previous exposure to survodutide, or history of relevant allergy or hypersensitivity (including allergy intolerability or lack of efficacy to trial medication or drugs that belongs to the GLP-1R agonist class).

•Trial participants with the following laboratory findings at screening are excluded:

-Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) elevation ≥3× upper limit of normal (ULN)

-Total bilirubin ≥1.2× ULN

-Calcitonin ≥100 picograms per milliliter (pg/mL) (29.26 picomoles per litre (pmol/L))

-Glycosylated hemoglobin A1c (N-(1-deoxy)-fructosyl-hemoglobin) (HbA1c) > upper limit of normal (ULN)

•History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x ULN as measured by the laboratory at screening

•further exclusion criteria apply

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

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

Time frame:up to 7 days

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

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

Time frame:up to 7 days

Cmax

concentration, descriptive

Primary/protocol endpoint

Cmax (maximum measured concentration of survodutide in plasma) after multiple doses

Time frame:up to 7 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

Percentage (%) of participants withdrawn due to adverse events from up-titration by dose

Time frame:up to 7 days

Discontinuation due to AE

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.