ClinicalTrials.gg
TerminatedNCT06417697Updated Sep 24, 2024

A Phase 1b Study to Evaluate the Safety of XEN-101

A Phase 1 interventional study of XEN-101 and Placebo in Obesity, sponsored by Xeno Biosciences. Terminated at 1 site in Australia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Xeno Biosciences · Phase 1, Interventional, and Treatment

Why this study was terminated
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.

From the registry’s dates

  • Primary completion was Sep 2024, 2 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity

Browse trials for

03

In context

Obesity

6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 33 is below the median of 77 across 5,091 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Xeno Biosciences is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, age 18 to 60 years, inclusive, at Screening
  2. Body mass index of 30 to 45 kg/m2
  3. Stable body weight for at least 3 months (i.e., fluctuation of ≤5%)
  4. 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
  5. If a female of childbearing potential, must have a negative pregnancy test at Screening and on Day 1 (baseline)
  6. Able to provide informed consent
  7. Willing and able to comply with this protocol and procedures, including feces collection, and be available for the entire duration of the study

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Diagnosed with type 1 diabetes or type 2 diabetes (T2D) (resolution of T2D >3 years before Screening is allowed)
  3. Laboratory evidence during Screening of T2D, including glycated hemoglobin (HbA1c) ≥6.5% or fasting glucose ≥126 mg/dL (≥7.0 mmol/L)
  4. 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
  5. Female who is pregnant, nursing, or intends to become pregnant during the study.
  6. Positive result for hepatitis B virus surface antigen, hepatitis C virus ribonucleic acid, and human immunodeficiency virus (HIV) antibody at Screening
  7. Use of anti-obesity medications (e.g., glucagon-like peptide-1 analogues, stimulants, bupropion/naltrexone) within 6 months before Screening
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    XEN-101

    Drug: XEN-101

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugXEN-101

    capsule formulation

  • DrugPlacebo

    capsule formulation

06

What researchers measure

Primary outcomes

  1. Incidence of treatment emergent adverse events (safety and tolerability)

    Assessing the type and frequency of adverse events

    Time frame: Day 1 through Day 43

  2. Effect on body weight

    change and percent change from baseline

    Time frame: Day 1 through Day 43

07

Study locations

1 site
  • Nucleus Network Pty Ltd
    Melbourne, Victoria 3004, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2024 to primary completion in Sep 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2024
First posted
May 16, 2024
StartActual
May 24, 2024
Primary completionActual
Sep 9, 2024
CompletionActual
Sep 9, 2024
Last update
Sep 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06417697
Lead sponsor
Xeno Biosciences
Responsible party
Sponsor
First posted
May 16, 2024
Start date
May 24, 2024
Primary completion
Sep 9, 2024
Completion
Sep 9, 2024
Last update
Sep 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion