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

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

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: XEN-101

Detailed Description

This study will assess the safety, tolerability and weight loss associated with XEN-101 in obese men and women.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; capsule formulation
Experimental: XEN-101	Drug: XEN-101; capsule formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events (safety and tolerability)	Assessing the type and frequency of adverse events	Day 1 through Day 43
Effect on body weight	change and percent change from baseline	Day 1 through Day 43

Collaborators and Investigators

• Sponsor: Xeno Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2024
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 11, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: XB-101-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes