ObesityPhase 1CYLOBNCT04449536
Cysteine-lowering Treatment With Mesna
A Phase 1 study testing Mesna in people with Obesity and Drug Effect, run by University of Oslo at 1 site in Norway.
Trial summary
The primary objective of this study is to determine the efficacy of the drug Mesna® (Uromitexan) in healthy participants with overweight or obesity with respect to change in plasma concentrations of total cysteine, following single ascending doses of oral Mesna. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Drug Effect
- What is being tested?
- Mesna
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 2 Nov 2020to 21 Oct 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between BMI 27-40 kg/m2
- Age between 18-55 years
- Male
- Healthy as determined by medical evaluation, medical history, physical examination, 12-lead ECG, and laboratory tests
Who cannot join
- Presence of chronic disease
- Chronic drug use
- Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing
- Veganism
- Strenuous physical activity ≥3 times every week
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cysteine-lowering Treatment With Mesna Against Obesity: Phase I Dose-finding Study
The primary objective of this study is to determine the efficacy of the drug Mesna® (Uromitexan) in healthy participants with overweight or obesity with respect to change in plasma concentrations of total cysteine, following single ascending doses of oral Mesna.
Read the detailed description
In both animal experiments and human studies, cysteine in the blood is strongly associated with obesity. In rodents, changes in cysteine induced by dietary means are accompanied by changes in fat mass.
In this phase I, single ascending dose study the investigators will determine the effects of Mesna in healthy volunteers with overweight and obesity with focus on its effects on plasma total cysteine concentrations. The aim of this dose-finding clinical trial is to determine the lowest single oral Mesna dose that will lower plasma total cysteine concentrations by 30% using pharmacokinetic (PK)/ pharmacodynamic (PD) modelling. The investigators will further evaluate the effect of Mesna on plasma cysteine fractions and related metabolites, urinary cysteine excretion, safety and adverse drug reactions, and plasma biomarkers.
- Conditions
- Obesity, Drug Effect
- Being tested
- Mesna
- Keywords
- Cysteine, Phase 1, Mesna
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesnaDrug
Also called Uromitexan
Administration of a single oral dose, using film-coated tablets of either 400 mg or 600 mg or a combination of maximum 3 tablets up to a maximum of 1600 mg
| Study group | Role | What they receive |
|---|---|---|
| Mesna | Experimental | Administration of a single oral dose of 400 mg, 800 mg, 1200 mg or 1600 mg Receives: Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma total cysteine concentrations following single ascending doses of oral Mesna.
Nadir plasma total cysteine concentrations
Measured: Several intervals during the first 12 hours after Mensa administration, and a fasting sample on days 2 and 3
Secondary outcomes (8)
Pharmacokinetic parameter - maximum plasma concentration (Cmax)
Maximum plasma Mesna concentration (Cmax) after a single oral Mesna dose
Measured: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - time to maximum plasma concentration (Tmax)
Time to maximum plasma Mesna concentration (Tmax) after a single oral Mesna dose
Measured: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC)
Area under the plasma Mesna concentration-time curve (AUC)0-inf after a single oral Mesna dose
Measured: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - elimination rate constant (Kel)
Elimination rate constant (Kel) for Mesna after a single oral Mesna dose
Measured: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - dose linearity
Dose linearity of Mesna after a single oral Mesna dose
Measured: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Change in plasma cystine, free reduced cysteine, and protein bound cysteine
Estimated AUCs
Measured: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Urine excretion of cysteine
Cumulative and fractional excretion of total cysteine and Mesna
Measured: During the first 24 hours after Mesna administration
Safety of Mesna
Occurrence/prevalence of side effects, adverse events, and serious adverse events
Measured: During the first 5 days after Mesna administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start2 Nov 2020
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Oxford
- Responsible party
- Principal investigator, Kathrine Vinknes, University of Oslo
- Investigators
- Kjetil Retterstøl, MD, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449536
- Sponsor's protocol ID
- EudraCT: 2019-003412-32
- Acronym
- CYLOB
- Status last verified
- May 2022
- First submitted
- 15 Jun 2020
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data that support the findings of this study may be available upon reasonable request from qualified users.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cysteine-lowering Treatment With Mesna Against Obesity: Phase I Dose-finding Study
- ClinicalTrials.gov ID
- NCT04449536
- Acronym / sponsor ID
- CYLOB / EudraCT: 2019-003412-32
- Conditions
- Obesity, Drug Effect
- Keywords
- Cysteine, Phase 1, Mesna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University of Oxford
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 29 Jun 2020 (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.
The primary objective of this study is to determine the efficacy of the drug Mesna® (Uromitexan) in healthy participants with overweight or obesity with respect to change in plasma concentrations of total cysteine, following single ascending doses of oral Mesna.
Detailed description
In both animal experiments and human studies, cysteine in the blood is strongly associated with obesity. In rodents, changes in cysteine induced by dietary means are accompanied by changes in fat mass.
In this phase I, single ascending dose study the investigators will determine the effects of Mesna in healthy volunteers with overweight and obesity with focus on its effects on plasma total cysteine concentrations. The aim of this dose-finding clinical trial is to determine the lowest single oral Mesna dose that will lower plasma total cysteine concentrations by 30% using pharmacokinetic (PK)/ pharmacodynamic (PD) modelling. The investigators will further evaluate the effect of Mesna on plasma cysteine fractions and related metabolites, urinary cysteine excretion, safety and adverse drug reactions, and plasma biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesna | Experimental | Drug: MesnaAdministration of a single oral dose of 400 mg, 800 mg, 1200 mg or 1600 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI between BMI 27-40 kg/m2
- Age between 18-55 years
- Male
- Healthy as determined by medical evaluation, medical history, physical examination, 12-lead ECG, and laboratory tests
Key exclusion criteria (6 listed)
- Presence of chronic disease
- Chronic drug use
- Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing
- Veganism
- Strenuous physical activity ≥3 times every week
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 |
|---|---|---|
| MesnaAlso: UromitexanAdministration of a single oral dose, using film-coated tablets of either 400 mg or 600 mg or a combination of maximum 3 tablets up to a maximum of 1600 mg | Drug | Mesna |
Primary outcome
Change in plasma total cysteine concentrations following single ascending doses of oral Mesna.
Time frame: Several intervals during the first 12 hours after Mensa administration, and a fasting sample on days 2 and 3
Nadir plasma total cysteine concentrations
8 secondary outcomes
Pharmacokinetic parameter - maximum plasma concentration (Cmax)
Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - time to maximum plasma concentration (Tmax)
Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC)
Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - elimination rate constant (Kel)
Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Pharmacokinetic parameter - dose linearity
Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Change in plasma cystine, free reduced cysteine, and protein bound cysteine
Time frame: Several intervals during the first 12 hours after Mesna administration, and a fasting sample on days 2 and 3
Urine excretion of cysteine
Time frame: During the first 24 hours after Mesna administration
Safety of Mesna
Time frame: During the first 5 days after Mesna administration
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 19 May 2022.
- Individual participant dataSharing planned: No. Data that support the findings of this study may be available upon reasonable request from qualified users.
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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.
Kjetil Retterstøl, MD, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesna in people with Obesity and Drug Effect, run by University of Oslo at 1 site in Norway.
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 4 inclusion and 6 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Change in plasma total cysteine concentrations following single ascending doses of oral Mesna. (time frame: Several intervals during the first 12 hours after Mensa administration, and a fasting sample on days 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.