ObesityPhase 1NCT06417697
A Phase 1b Study to Evaluate the Safety of XEN-101
A Phase 1 study testing XEN-101 in people with Obesity, run by Xeno Biosciences at 1 site in Australia.
Trial summary
This Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- XEN-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteAustralia
- Study dates
- 24 May 2024to 9 Sep 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, age 18 to 60 years, inclusive, at Screening
- Body mass index of 30 to 45 kg/m2
- Stable body weight for at least 3 months (i.e., fluctuation of ≤5%)
- If a female of childbearing potential, must agree to use double barrier contraception (e.g., condom and 1 additional form of adequate contraception) from the date of signing of the ICF, throughout the study, and for 4 weeks after the final dose of study drug. In addition, she must be advised not to donate ova during this period. If a non-sterilized male is sexually active with a female partner of childbearing potential, he must use double barrier contraception from the date of signing of the ICF, throughout the study, and for 8 weeks after the final dose of study drug. In addition, he must be advised not to donate sperm during this period
- If a female of childbearing potential, must have a negative pregnancy test at Screening and on Day 1 (baseline)
- Able to provide informed consent
- Willing and able to comply with this protocol and procedures, including feces collection, and be available for the entire duration of the study
Who cannot join
- Currently enrolled in another investigational device or drug study, or less than 30 days or 5 times the half-life of the drug candidate (whichever is longer) has passed between Screening for this study and the end of the Treatment Period of the previous investigational device or drug study
- Diagnosed with type 1 diabetes or type 2 diabetes (T2D) (resolution of T2D >3 years before Screening is allowed)
- Laboratory evidence during Screening of T2D, including glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
- Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the Investigator's opinion, would compromise the safety of the subject, interfere with the interpretation of the study results, or otherwise preclude subject participation
- Female who is pregnant, nursing, or intends to become pregnant during the study.
- Positive result for hepatitis B virus surface antigen, hepatitis C virus ribonucleic acid, and human immunodeficiency virus (HIV) antibody at Screening
- Use of anti-obesity medications (e.g., glucagon-like peptide-1 analogues, stimulants, bupropion/naltrexone) within 6 months before Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Effects of XEN-101 on Safety, Tolerability, and Pharmacodynamics in Subjects with Obesity
This Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity
Read the detailed description
This study will assess the safety, tolerability and weight loss associated with XEN-101 in obese men and women.
- Conditions
- Obesity
- Being tested
- XEN-101, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN-101Drug
capsule formulation
PlaceboDrug
capsule formulation
| Study group | Role | What they receive |
|---|---|---|
| XEN-101 | Experimental | Not described Receives: Drug: XEN-101 |
| 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.
Incidence of treatment emergent adverse events (safety and tolerability)
Assessing the type and frequency of adverse events
Measured: Day 1 through Day 43
Effect on body weight
change and percent change from baseline
Measured: Day 1 through Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start24 May 2024
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Why it stopped: Study not stopped for safety reasons. Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeno Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417697
- Sponsor's protocol ID
- XB-101-102
- Status last verified
- Sep 2024
- First submitted
- 8 May 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Effects of XEN-101 on Safety, Tolerability, and Pharmacodynamics in Subjects with Obesity
- ClinicalTrials.gov ID
- NCT06417697
- Acronym / sponsor ID
- XB-101-102
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study not stopped for safety reasons. Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Xeno BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 16 May 2024 (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 Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity
Detailed description
This study will assess the safety, tolerability and weight loss associated with XEN-101 in obese men and women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XEN-101 | Experimental | Drug: XEN-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, age 18 to 60 years, inclusive, at Screening
- Body mass index of 30 to 45 kg/m2
- Stable body weight for at least 3 months (i.e., fluctuation of ≤5%)
- If a female of childbearing potential, must agree to use double barrier contraception (e.g., condom and 1 additional form of adequate contraception) from the date of signing of the ICF, throughout the study, and for 4 weeks after the final dose of study drug. In addition, she must be advised not to donate ova during this period. If a non-sterilized male is sexually active with a female partner of childbearing potential, he must use double barrier contraception from the date of signing of the ICF, throughout the study, and for 8 weeks after the final dose of study drug. In addition, he must be advised not to donate sperm during this period
- If a female of childbearing potential, must have a negative pregnancy test at Screening and on Day 1 (baseline)
Key exclusion criteria (7 listed)
- Currently enrolled in another investigational device or drug study, or less than 30 days or 5 times the half-life of the drug candidate (whichever is longer) has passed between Screening for this study and the end of the Treatment Period of the previous investigational device or drug study
- Diagnosed with type 1 diabetes or type 2 diabetes (T2D) (resolution of T2D >3 years before Screening is allowed)
- Laboratory evidence during Screening of T2D, including glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
- Evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the Investigator's opinion, would compromise the safety of the subject, interfere with the interpretation of the study results, or otherwise preclude subject participation
- Female who is pregnant, nursing, or intends to become pregnant during the study.
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 |
|---|---|---|
| XEN-101capsule formulation | Drug | XEN-101 |
| Placebocapsule formulation | Drug | Placebo |
Primary outcome
Incidence of treatment emergent adverse events (safety and tolerability)
Time frame: Day 1 through Day 43
Assessing the type and frequency of adverse events
Effect on body weight
Time frame: Day 1 through Day 43
change and percent change from baseline
Results and safety
The study was stopped early (reason given: Study not stopped for safety reasons. Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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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 XEN-101 in people with Obesity, run by Xeno Biosciences at 1 site in Australia.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Sep 2024. 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 Australia. 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 was stopped early (reason given: Study not stopped for safety reasons. Data were reviewed after the first 23 patients had completed scheduled dosing and there was no signal of efficacy for change in body weight. This clinical trial has been determined to be futile.). Results are not available in the source record.
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?
Incidence of treatment emergent adverse events (safety and tolerability) (time frame: Day 1 through Day 43). The study lists 2 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 24 Sep 2024.