A study to test whether BI 456906 helps people living with overweight or obesity who do not have diabetes to lose weight

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

18 Jan 2024 → 17 Feb 2026

Decision date (initial)

2024-01-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2022-502529-17-00

WHO UTN

U1111-1288-9400

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy

This trial aims to investigate efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in trial participants with a BMI ≥30 kg/m^2 or a BMI ≥27 kg/m^2 with at least one weight-related complication but without T2DM.
Primary objective is to demonstrate superiority of survodutide low and high dose against placebo.

Secondary objectives 1

1. Demonstrate superiority of survodutide low dose and high dose against placebo in regards to the secondary endpoints listed in section 2.1.3 of the CTP.

Conditions and MedDRA coding

Obesity

Study design 5 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Center For Drug Evaluation, Pharmaceuticals And Medical Devices Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
2. BMI ≥30 kg/m² at screening, OR BMI ≥27 kg/m² with the presence of at least one of the following weight-related complications (treated or untreated): - Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, SBP values of ≥140 mmHg and/or DBP values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) - Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or LDL cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or HDL cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL cholesterol <50 mg/dL (<1.3 mmol/L) for women) - Obstructive sleep apnoea - CVD (e.g. HF with NYHA functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease) - NASH, as assessed in medical records by histological liver assessment (within the last 6 months)
3. History of at least one self-reported unsuccessful dietary effort to lose body weight
4. Further inclusion criteria apply.

Exclusion criteria 11

1. Body weight change (self-reported) of >5% within 3 months before screening
2. Treatment with any medication for the indication obesity within 3 months before screening
3. HbA1c ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
4. History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before the screening visit up to and including the randomisation visit
5. QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
6. HF with NYHA functional class IV
7. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
8. History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening
9. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
10. Trial participants who demonstrate recent evidence (within 3 months prior to screening) of acute or unstable cardiovascular events, e.g. hospitalisation for HF, acute coronary syndrome, unstable angina, MI, ischaemic or haemorrhagic stroke, transient ischaemic attack, and/or acute peripheral vascular event
11. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Percentage change in body weight from baseline to Week 76
2. Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

Secondary endpoints 4

1. Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
2. Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
3. Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
4. Absolute change from baseline to Week 76 in: o Body weight (kg) o Waist circumference (cm) o Systolic blood pressure (SBP) (mmHg) o “Capacity to Resist” domain score of the Eating Behaviour PRO (units on scale) o Eating Behaviour PRO total score (units on scale)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 1

Boehringer Ingelheim RCV GmbH & Co. KG

Sponsor organisation

Boehringer Ingelheim RCV GmbH & Co. KG

Address

Dr.-Boehringer-Gasse 5-11, Meidling Meidling

City

Vienna

Postcode

1121

Country

Austria

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

6 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 155 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications