Obese Adult MalePhase 1NCT04018339
A Study of RTA 402 in Obese Adults
A Phase 1 study testing Bardoxolone methyl in people with Obese Adult Male, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control. Read more about this study
- Who is it for?
- Ages 20 to 49 years, men only
- Conditions the study is for
- Obese Adult Male
- What is being tested?
- Bardoxolone methyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteJapan
- Study dates
- 20 Aug 2019to 18 Jun 2020
- 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 20 to 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Written voluntary informed consent to participate in the study
- Male aged ≥ 20 and < 50 years at the time of consent
- BMI ≥ 25.0 kg/m2 measured at screening
- Waist circumference (umbilical position) ≥ 85 cm measured at screening.
- MRI-measured visceral fat area ≥ 100 cm2 measured at screening
Who cannot join
- Subjects who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening
- Subjects with conditions requiring treatment other than obesity
- History of cardiac failure (e.g., a prior diagnosis of congestive cardiac failure defined as NYHA class III or IV or a history of hospitalization for cardiac failure)
Trial locations and contacts
1 site in 1 country.
Japan1 site
Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, 830-0011
About this study
Official title: Phase I Study of RTA 402 in Obese Adults
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
- Conditions
- Obese Adult Male
- Being tested
- Bardoxolone methyl, Placebo
- Keywords
- Bardoxolone Methyl, Obese adult, body weight, body composition
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methylDrug
Also called RTA 402
Bardoxolone methyl 5 mg capsules
PlaceboDrug
Capsules containing an inert placebo
| Study group | Role | What they receive |
|---|---|---|
| RTA 402 5mg or 10mg oral administration | Experimental | Not described Receives: Drug: Bardoxolone methyl |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in weight measured by Bioelectrical Impedance Analysis
Measured: Through study completion, approximately 6 months
Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
Measured: Through study completion, approximately 6 months
Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
Measured: Through study completion, approximately 6 months
Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
Measured: Through study completion, approximately 6 months
Changes from baseline in waist
Measured: Through study completion, approximately 6 months
Changes from baseline in grip
Measured: Through study completion, approximately 6 months
Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
Measured: Through study completion, approximately 6 months
Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
Measured: Through study completion, approximately 6 months
Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
Measured: Through study completion, approximately 6 months
Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
Measured: Through study completion, approximately 6 months
Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
Measured: Through study completion, approximately 6 months
Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
Measured: Through study completion, approximately 6 months
Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
Measured: Through study completion, approximately 6 months
Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
Measured: Through study completion, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start20 Aug 2019
- Primary completion28 May 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Adult MaleStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018339
- Sponsor's protocol ID
- RTA 402-010
- Status last verified
- Jun 2020
- First submitted
- 10 Jul 2019
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of RTA 402 in Obese Adults
- ClinicalTrials.gov ID
- NCT04018339
- Acronym / sponsor ID
- RTA 402-010
- Conditions
- Obese Adult Male
- Keywords
- Bardoxolone Methyl, Obese adult, body weight, body composition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 12 Jul 2019 (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.
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTA 402 5mg or 10mg oral administration | Experimental | Drug: Bardoxolone methyl |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written voluntary informed consent to participate in the study
- Male aged ≥ 20 and < 50 years at the time of consent
- BMI ≥ 25.0 kg/m2 measured at screening
- Waist circumference (umbilical position) ≥ 85 cm measured at screening.
- MRI-measured visceral fat area ≥ 100 cm2 measured at screening
Key exclusion criteria (3 listed)
- Subjects who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening
- Subjects with conditions requiring treatment other than obesity
- History of cardiac failure (e.g., a prior diagnosis of congestive cardiac failure defined as NYHA class III or IV or a history of hospitalization for cardiac failure)
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 |
|---|---|---|
| Bardoxolone methylAlso: RTA 402Bardoxolone methyl 5 mg capsules | Drug | RTA 402 5mg or 10mg oral administration |
| PlaceboCapsules containing an inert placebo | Drug | Placebo |
Primary outcome
Changes from baseline in weight measured by Bioelectrical Impedance Analysis
Time frame: Through study completion, approximately 6 months
Changes from baseline in fat mass measured by Dual Energy X-ray Absorption
Time frame: Through study completion, approximately 6 months
Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption
Time frame: Through study completion, approximately 6 months
Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption
Time frame: Through study completion, approximately 6 months
Changes from baseline in waist
Time frame: Through study completion, approximately 6 months
Changes from baseline in grip
Time frame: Through study completion, approximately 6 months
Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging
Time frame: Through study completion, approximately 6 months
Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging
Time frame: Through study completion, approximately 6 months
Changes from baseline in muscle mass measured by Magnetic Resonance Imaging
Time frame: Through study completion, approximately 6 months
Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis
Time frame: Through study completion, approximately 6 months
Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis
Time frame: Through study completion, approximately 6 months
Changes from baseline in total body water measured by Bioelectrical Impedance Analysis
Time frame: Through study completion, approximately 6 months
Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis
Time frame: Through study completion, approximately 6 months
Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis
Time frame: Through study completion, approximately 6 months
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 23 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Bardoxolone methyl in people with Obese Adult Male, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 5 inclusion and 3 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 23 Jun 2020. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
Changes from baseline in weight measured by Bioelectrical Impedance Analysis (time frame: Through study completion, approximately 6 months). The study lists 14 primary outcomes in all. 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 23 Jun 2020.