Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
1
Obesity
To evaluate the efficacy and safety of pharmacological obesity treatment (BMI ≥ 30) in liver transplant candidates.
Key facts
- Sponsor
- Institute For Clinical And Experimental Medicine
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2026-03-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- institut klinické a experimentální medicíny · Agentura pro zdravotnický výzkum České republiky
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To evaluate the efficacy and safety of pharmacological obesity treatment (BMI ≥ 30) in liver transplant candidates.
Conditions and MedDRA coding
Obesity
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Liver transplant candidate undergoing pre-transplant evaluation (inpatient or outpatient) at the Department of Hepatogastroenterology, aged ≥18 years.
- BMI ≥ 30, or BMI ≥ 33 in case of significant fluid retention (edema of lower extremities, ascites, hydrothorax; for large ascites/hydrothorax, BMI will be evaluated after evacuation puncture).
- Clinically stable (patient is at home under outpatient follow-up or hospitalized on a standard ward without clinical or laboratory signs of significant deterioration or complications).
- Signed informed consent.
Exclusion criteria 12
- Hepatic encephalopathy
- History of acute or chronic pancreatitis.
- Polycystic liver disease
- Type 1 diabetes mellitus
- Liver malignancy outside Milan criteria (Milan-out, Klatskin tumor, colorectal carcinoma metastases, NET metastases).
- Unstable clinical condition or unplanned hospitalization due to significant deterioration or complication.
- Spontaneous weight loss (≥5% in the past 6 months, not due to diuretic or evacuation treatment).
- Sarcopenia according to pre-transplant CT.
- Inability to perform physical activity (walking 30 min/day).
- Refractory ascites/hydrothorax (≥2 evacuation procedures in the last 2 months).
- Combined liver-kidney transplantation.
- Pregnancy (pre-enrollment assessment includes a pregnancy test; women of childbearing potential must agree to use highly effective contraception — hormonal or barrier methods, or abstinence; highly effective methods are defined as those with failure rate <1% per year with correct and consistent use).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Absolute and relative change in body weight/BMI/body fat composition during the follow-up period.
Secondary endpoints 5
- Occurrence of complications while on the waiting list (WL) related to the underlying liver disease
- Safety of treatment (adverse events)
- Post-transplant complications (1M, 3M, 6M)
- Patient survival (1M, 3M, 6M)
- Graft survival (1M, 3M, 6M)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Mounjaro 5 mg solution for injection in pre-filled pen
PRD9945973 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-L-.ALPHA.-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L- .ALPHA.-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-.ALPHA.-ASPARTYL-L-LYSYL-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 2 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/005
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mounjaro 2.5 mg solution for injection in pre-filled pen
PRD9947525 · Product
- Active substance
- Tirzepatide
- Substance synonyms
- LY3298176, LY-3298176, L-TYROSYL-2-METHYLALANYL-L-.ALPHA.-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L- .ALPHA.-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-.ALPHA.-ASPARTYL-L-LYSYL-LISOLEUCYL- L-ALANYL-L-GLUTAMINYL-N6-((22S)-22,42-DICARBOX
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
- Marketing authorisation
- EU/1/22/1685/002
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institute For Clinical And Experimental Medicine
- Sponsor organisation
- Institute For Clinical And Experimental Medicine
- Address
- Videnska 1958/9, Krc Krc
- City
- Prague
- Postcode
- 140 00
- Country
- Czechia
Scientific contact point
- Organisation
- Institute For Clinical And Experimental Medicine
- Contact name
- prof. MUDr. Tomáš Hucl, Ph.D.
Public contact point
- Organisation
- Institute For Clinical And Experimental Medicine
- Contact name
- prof. MUDr. Tomáš Hucl, Ph.D.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | dotaznik SF-36 | 1 |
| Protocol (for publication) | dotaznik WONCA | 1 |
| Protocol (for publication) | Mezinarodni_dotaznik_IPAQ_Archive | 1 |
| Protocol (for publication) | Navod na vyplneni dotazniku WONCA | 1 |
| Protocol (for publication) | Procotol | 1 |
| Recruitment arrangements (for publication) | Dotaznik IPAQ_v2 | 2 |
| Recruitment arrangements (for publication) | Dotaznik SF-36_v2 | 2 |
| Recruitment arrangements (for publication) | Dotaznik WONCA_v2 | 2 |
| Recruitment arrangements (for publication) | Sablona-1__Hucl tirzepatid_final | 1 |
| Subject information and informed consent form (for publication) | GDPR_Hucl_final | 1 |
| Subject information and informed consent form (for publication) | Informovany souhlas a informace pro pacienta_Hucl tirzepatid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC tirzepatid | 1 |
| Synopsis of the protocol (for publication) | Souhrn protokolu | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-09 | Czechia | Acceptable 2026-03-12
|
2026-03-18 |