Current partner codePEPTIDESDE
NCT06492135·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

30

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study is open to Chinese adults aged 18 to 60 with overweight or obesity. People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2. Survodutide is a medicine being developed to help people with overweight or obesity. The purpose of this study is to find out how different doses of survodutide are taken up in the body. Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity. Participants receive survodutide as an injection under the skin once a week for 7.5 months. During this time, participants visit the study site 33 times. 4 of the visits require a stay in the hospital. At the visits, doctors take blood samples to measure the levels of survodutide in participants' blood. The doctors also check participants' health and take note of any unwanted effects.

Interventions

Treatment arms and agents.

DRUG

survodutide

survodutide

Timeline

From registration to results.

  1. First posted

    Jul 9, 2024

  2. Study start

    Aug 12, 2024

  3. Primary completion

    Apr 15, 2025

  4. Study completion

    Apr 15, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Apr 23, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

Time frame · up to 7 days

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

Time frame · up to 7 days

Secondary outcomes

Percentage (%) of participants withdrawn due to adverse events from up-titration by dose

Time frame · up to 7 days

Eligibility

Who can take part.

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

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

Study locations

1 registered sites.

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

Shanghai Central Hospital of Xuhui District

Shanghai, China

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.