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)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: survodutide

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200031
    • Shanghai Central Hospital of Xuhui District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Participants with a body mass index (BMI) ranging from ≥27.0 kg/m² to ≤40.0 kg/m²	Drug: survodutide; survodutide
Experimental: Arm 2: Participants with a body mass index (BMI) ranging from ≥24.0 kg/m² to <27.0 kg/m²	Drug: survodutide; survodutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-168 (area under the concentration-time curve of survodutide in plasma over the time interval from 0 to 168h)	up to 7 days
Cmax (maximum measured concentration of survodutide in plasma) after the first dose	up to 7 days
Cmax (maximum measured concentration of survodutide in plasma) after multiple doses	up to 7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage (%) of participants withdrawn due to adverse events from up-titration by dose	up to 7 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 1404-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes