HealthyPhase 1NCT05296733
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
A Phase 1 study testing BI 456906 in people with Healthy and Liver Diseases, run by Boehringer Ingelheim at 13 sites in 6 countries.
Trial summary
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Healthy, Liver Diseases, Obesity
- What is being tested?
- BI 456906
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 27 Apr 2022to 29 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with age ≥18 years (or the minimum country specific age of consent if >18 years) and 75 years, inclusive at the screening visit.
- Body mass index (BMI) of 18.5-40.0 kg/m2 (inclusive).
- Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Women of childbearing potential must be willing and able to use two forms of effective contraception where at least one form is highly effective method of birth control per ICH M3 (R2) that results in a low failure rate (i.e. <1% per year when used consistently and correctly). A list of contraception methods meeting these criteria is provided in the subject information. Please note that oral contraceptives are not allowed during the treatment period.
- A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Further inclusion criteria apply.
Show all 12Show fewer
- -Part B:
- Male or female subjects between the ages of ≥18 (or the minimum country specific age of consent if >18 years) and 75 years, inclusive, at the screening visit.
- Subjects with overweight or obesity, defined as BMI ≥27 kg/m2 at the screening visit.
- A minimum absolute body weight of 70 kg for females and 80 kg for males at the screening visit.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Further inclusion criteria apply.
Who cannot join
- Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening.
- Calcitonin ≥20 pg/mL (5.84 pmol/L) at the screening visit.
- History of chronic or acute pancreatitis or elevation of serum lipase/amylase >2×ULN, or fasting serum triglyceride levels of >500 mg/dL (>5.65 mmol/L) at screening.
- Further exclusion criteria apply.
- -Part B:
Show all 11Show fewer
- Prior surgery of the gastrointestinal tract that could interfere with body weight (including minimally invasive/endoscopic bariatric devices, bariatric surgery including metabolic operation that involves resection and/or reconstruction of any portion of the gastrointestinal tract) except appendectomy and simple hernia repair before randomization. However, a subject previously treated with reversible weight loss devices such as gastric banding, or intragastric balloon and removed longer than 12 months before screening should not be excluded.
- Glycosylated Hemoglobin, Type A1 (HbA1c) ≥11% at screening or diagnosed with type 1 diabetes mellitus.
- Exposure to Glucagon-like-peptide 1 (GLP-1) receptor agonist-based therapies (within 3 months prior to screening or within 5 half-lives of the drug, whichever is longer).
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening.
- Further exclusion criteria apply.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
United States5 sites
Arizona Liver Health
Chandler, Arizona, 85224
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, 33912
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
Covenant Metabolic Specialists, LLC
Sarasota, Florida, 34240
Germany3 sites
Universitätsklinikum Bonn AöR
Bonn, 53127
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinikum Ulm
Ulm, 89081
Hungary2 sites
Semmelweis University
Budapest, 1083
CRU Hungary Ltd.
Kistarcsa, 2140
About this study
Official title: A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part.
This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906.
Read more
In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems.
In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems.
In both parts, doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Healthy, Liver Diseases, Obesity
- Being tested
- BI 456906
- Medical subject headings
- Liver Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 456906Drug
Also called survodutide
BI 456906
| Study group | Role | What they receive |
|---|---|---|
| Part A: BI 456906: Cohort 1 | Experimental | Healthy subjects Receives: Drug: BI 456906 |
| Part A: BI 456906: Cohort 2 | Experimental | Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A Receives: Drug: BI 456906 |
| Part A: BI 456906: Cohort 3 | Experimental | Patients with cirrhosis + CTP Class B Receives: Drug: BI 456906 |
| Part A: BI 456906: Cohort 4 | Experimental | Patients with cirrhosis + CTP Class C Receives: Drug: BI 456906 |
| Part B: BI456906: Cohort 1 | Experimental | Patients with overweight/obesity without cirrhosis/hepatic impairment Receives: Drug: BI 456906 |
| Part B: BI456906: Cohort 2 | Experimental | Patients with overweight/obesity with cirrhosis + CTP Class A Receives: Drug: BI 456906 |
| Part B: BI456906: Cohort 3 | Experimental | Patients with overweight/obesity with cirrhosis + CTP Class B Receives: Drug: BI 456906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: Up to 360 hours
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
Measured: Up to 360 hours
Part B: Percentage of patients treated who experience treatment-emergent adverse event
Measured: Up to Day 218
Secondary outcomes (1)
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Measured: Up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start27 Apr 2022
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296733
- Sponsor's protocol ID
- 1404-0010
- Other IDs
- 2021-006247-10
- Status last verified
- Aug 2024
- First submitted
- 23 Mar 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Lawitz EJ, Fraessdorf M, Neff GW, Schattenberg JM, Noureddin M, Alkhouri N, Schmid B, Andrews CP, Takacs I, Hussain SA, Fenske WK, Gane EJ, Hosseini-Tabatabaei A, Sanyal AJ, Mazo DF, Younes R; NCT05296733 Investigators. Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis. J Hepatol. 2024 Nov;81(5):837-846. doi: 10.1016/j.jhep.2024.06.003. Epub 2024 Jun 8.
PubMed 38857788
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05296733
- Acronym / sponsor ID
- 1404-0010
- Conditions
- Healthy, Liver Diseases, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part.
This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906.
In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems.
In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems.
In both parts, doctors also regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: BI 456906: Cohort 1 | Experimental | Drug: BI 456906Healthy subjects |
| Part A: BI 456906: Cohort 2 | Experimental | Drug: BI 456906Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A |
| Part A: BI 456906: Cohort 3 | Experimental | Drug: BI 456906Patients with cirrhosis + CTP Class B |
| Part A: BI 456906: Cohort 4 | Experimental | Drug: BI 456906Patients with cirrhosis + CTP Class C |
| Part B: BI456906: Cohort 1 | Experimental | Drug: BI 456906Patients with overweight/obesity without cirrhosis/hepatic impairment |
| Part B: BI456906: Cohort 2 | Experimental | Drug: BI 456906Patients with overweight/obesity with cirrhosis + CTP Class A |
| Part B: BI456906: Cohort 3 | Experimental | Drug: BI 456906Patients with overweight/obesity with cirrhosis + CTP Class B |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects with age ≥18 years (or the minimum country specific age of consent if >18 years) and 75 years, inclusive at the screening visit.
- Body mass index (BMI) of 18.5-40.0 kg/m2 (inclusive).
- Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Women of childbearing potential must be willing and able to use two forms of effective contraception where at least one form is highly effective method of birth control per ICH M3 (R2) that results in a low failure rate (i.e. <1% per year when used consistently and correctly). A list of contraception methods meeting these criteria is provided in the subject information. Please note that oral contraceptives are not allowed during the treatment period.
- A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Key exclusion criteria (11 listed)
- Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening.
- Calcitonin ≥20 pg/mL (5.84 pmol/L) at the screening visit.
- History of chronic or acute pancreatitis or elevation of serum lipase/amylase >2×ULN, or fasting serum triglyceride levels of >500 mg/dL (>5.65 mmol/L) at screening.
- Further exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 456906Also: survodutideBI 456906 | Drug | Part A: BI 456906: Cohort 1, Part A: BI 456906: Cohort 2, Part A: BI 456906: Cohort 3, Part A: BI 456906: Cohort 4, Part B: BI456906: Cohort 1, Part B: BI456906: Cohort 2, Part B: BI456906: Cohort 3 |
Primary outcome
Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 360 hours
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
Time frame: Up to 360 hours
Part B: Percentage of patients treated who experience treatment-emergent adverse event
Time frame: Up to Day 218
1 secondary outcome
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Time frame: Up to Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 38857788Lawitz EJ, Fraessdorf M, Neff GW, Schattenberg JM, Noureddin M, Alkhouri N, Schmid B, Andrews CP, Takacs I, Hussain SA, Fenske WK, Gane EJ, Hosseini-Tabatabaei A, Sanyal AJ, Mazo DF, Younes R; NCT05296733 Investigators. Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis. J Hepatol. 2024 Nov;81(5):837-846. doi: 10.1016/j.jhep.2024.06.003. Epub 2024 Jun 8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 456906 in people with Healthy and Liver Diseases, run by Boehringer Ingelheim at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Germany, Hungary, New Zealand, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to 360 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.