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

NCT06492135 | Completed Phase 1 FDA Drug

• 1 other identifier: 1404-0013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Percentage (%) of participants withdrawn due to adverse events from up-titration by dose

  up to 7 days

Study Arms (2)

Arm 1: Participants with a body mass index (BMI) ranging from ≥27.0 kg/m² to ≤40.0 kg/m²

EXPERIMENTAL

Drug: survodutide

Arm 2: Participants with a body mass index (BMI) ranging from ≥24.0 kg/m² to <27.0 kg/m²

EXPERIMENTAL

Drug: survodutide

Interventions

survodutide DRUG

survodutide

Arm 1: Participants with a body mass index (BMI) ranging from ≥27.0 kg/m² to ≤40.0 kg/m²; Arm 2: Participants with a body mass index (BMI) ranging from ≥24.0 kg/m² to <27.0 kg/m²

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese ethnicity
• Age of 18 to 60 years
• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Shanghai Central Hospital of Xuhui District

Shanghai, 200031, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 12, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)