Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
700
Countries
3
Sites
12
Obesity Overweight
To demonstrate that tirzepatide at MTD is superior to semaglutide 2.4 mg for the mean percent decrease in weight loss
Key facts
- Sponsor
- Eli Lilly & Co.
- 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
- completed 10 Oct 2023
- Decision date (initial)
- 2023-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501106-35-00
- WHO UTN
- U1111-1283-5404
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To demonstrate that tirzepatide at MTD is superior to semaglutide 2.4 mg for the mean percent decrease in weight loss
Secondary objectives 2
- To demonstrate that tirzepatide at MTD is superior to semaglutide 2.4 mg at Week 72 for body weight and waist circumference
- To compare tirzepatide MTD to semaglutide 2.4 mg at Week 72 for body weight and BMI
Conditions and MedDRA coding
Obesity Overweight
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Parallel Assignment N/A
|
Randomised Controlled | None | Test: Tirzepatide: Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose Comparator: Semaglutide: Participants will receive escalated doses of semaglutide subcutaneously (SC) up to 2.4mg |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Have obesity
- Have overweight with at least one: Obstructive sleep apnea, have high blood pressure, have high cholesterol, have heart disease
Exclusion criteria 5
- Have type 1 or type 2 diabetes
- Have a self-reported change in body weight over 5 kg within 3 months before screening
- Have a planned or prior surgery for obesity
- Have “severe” kidney impairment
- Have long-term or short- term inflammation of the pancreas
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Body Weight
Secondary endpoints 7
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction
- Percentage of Participants Who Achieve ≥20% Body Weight Reduction
- Percentage of Participants Who Achieve ≥25% Body Weight Reduction
- Change from Baseline in Waist Circumference Centimeter (cm)
- Change from Baseline in Who Achieve ≥30% Body Weight Reduction
- Change from Baseline in Body Mass Index (BMI)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD7107378 · Product
- Active substance
- LY3298176
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.14 mg milligram(s)
- Max total dose
- 1.08 g gram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107377 · Product
- Active substance
- LY3298176
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.14 mg milligram(s)
- Max total dose
- 1.08 g gram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107375 · Product
- Active substance
- LY3298176
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.14 mg milligram(s)
- Max total dose
- 1.08 g gram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107376 · Product
- Active substance
- LY3298176
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.14 mg milligram(s)
- Max total dose
- 1.08 g gram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107380 · Product
- Active substance
- LY3298176
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.14 mg milligram(s)
- Max total dose
- 1.08 g gram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107379 · Product
- Active substance
- LY3298176
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 2.14 mg milligram(s)
- Max total dose
- 1.08 g gram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 172.8 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 172.8 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 172.8 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 172.8 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 172.8 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
| Cleveland Clinic ORG-100028017
|
Cleveland, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | E-data capture |
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 38 | 4 |
| Germany | Ended | 50 | 5 |
| Poland | Ended | 55 | 3 |
| Rest of world
Brazil, United States, Canada, Argentina, United Kingdom
|
— | 557 | — |
Investigational sites
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Endocrinology-Diabetology-Metabolism, Drie Eikenstraat 655, 2650, Edegem
Algemeen Ziekenhuis Damiaan Oostende
Endocrinology, Gouwelozestraat 100, 8400, Ostend
Az Delta
Endocrinologie, Deltalaan 1, 8800, Roeselare
ClinPhenomics CVC GmbH
ClinPhenomics CVC GmbH, Studienzentrum, Alfred-Lippmann-Straße 6, Rohrbach, St. Ingbert
Innodiab Forschung GmbH
InnoDiab Forschung GmbH, Eleonorastrasse 42, Ruettenscheid, Essen
Praxisinhaber Dr Ulrich Wendisch Dr Dominik Dahl Und Prof Dr Jens Aberle
Praxis für Diabetologie, Endokrinologie und Innere Medizin, Beselerstraße 2a, Groß Flottbek, Hamburg
Ambenet GmbH Das Ambulante Behandlungsnetz
AmBeNet GmbH, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Medizentrum Essen Borbeck
Medizentrum Essen Borbeck,, Hülsmannstraße 6, Borbeck, Essen
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-11 | Belgium | Acceptable with conditions 2023-01-26
|
2023-01-26 |