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

NCT06417697 | Terminated Phase 1 FDA Drug

• 1 other identifier: XB-101-102
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1b study will evaluate the effects of XEN-101 in subjects with obesity

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

XEN-101

EXPERIMENTAL

Drug: XEN-101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

XEN-101 DRUG

capsule formulation

XEN-101

Placebo DRUG

capsule formulation

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xeno Biosciences: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 16, 2024
• Study Start: May 24, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)