NCT06471530

A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes

A Phase 1/2a, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Body Weight of TE-8105 Administered Subcutaneously in Overweight/Obese Participants Without Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Immunwork, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1/2a, first-in-human, prospective, open-label study to evaluate the safety, tolerability, PK, PD, and effect on body weight of TE-8105 in overweight/obese participants without diabetes. Study TE-8105-101 consists of 2 parts: Part A (single-ascending dose \[SAD\]) and Part B (multiple-ascending dose \[MAD\])

Detailed description

Part A consists of 4 cohorts, with an optional adaptive cohort which may be opened if needed approximately 24 eligible participants will be assigned to Part A (SAD) (6 participants in each cohort). Part A is designed to evaluate the safety, tolerability, PK and effect on body weight of a single dose of 0.5 mg, 0.75 mg, 1.5 mg (or ≤ 2.5 mg), 3 mg (or ≤ 5 mg) TE-8105. Each participant will receive one dose of TE-8105 injection via subcutaneous (SC) injection into the abdomen administered on Day 1. Part B consists of 2 cohorts. Approximately 14 participants will be assigned to Part B (MAD) (6 participants in B1 and 8 in B2 cohort). Part B is designed to evaluate the safety, tolerability, PK, PD, and effect on body weight of multiple SC doses 0.5 mg up to 3mg TE-8105 once every 2 weeks (Q2W). The dose levels and dosing interval of Part B may be adjusted based on the results of Part A. Each participant will receive 5 doses or 9 doses of TE-8105 injection via SC injection into the abdomen. Progression from Part A to Part B will be based on the recommendation of the SRC.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	TE-8105 SAD Cohort 1	Each participant will receive one dose of TE-8105 0.5 up to 1.5mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.
DRUG	TE-8105 SAD Cohort 3	Each participant will receive one dose of TE-8105 1.5 mg or less than or equal to 2.5 mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.
DRUG	TE-8105 SAD Cohort 5 (Adaptive cohort)	Each participant will receive one dose of TE-8105 less than or equal to 6 mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.
DRUG	TE-8105 MAD Cohort 1	Each participant will receive 0.5mg up to 1.5mg of TE-8105 injection via SC injection into the abdomen on Day 1 and then once every 2 weeks for 5 doses.
DRUG	TE-8105 MAD Cohort 2	Each participant will receive 9 doses of TE-8105 injection via SC injection into the abdomen starting from Day 1 every 2 weeks. Dose will be titrated up by 0.5mg every 4 weeks, with dose levels of 1.5mg (2 doses), 2.0 mg (2 doses), 2.5 mg (2 doses) and 3.0 mg (3 doses)
DRUG	TE-8105 SAD Cohort 2	Each participant will receive one dose of TE-8105 0.75mg injection via subcutaneous (SC) injection into the abdomen on Day 1.
DRUG	TE-8105 SAD Cohort 4	Each participant will receive one dose of TE-8105 3 mg or less than or equal to 5 mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.

Timeline

• Start date: 2024-07-09
• Primary completion: 2025-01-03
• Completion: 2025-06-07
• First posted: 2024-06-24
• Last updated: 2026-01-09

Locations

1 site across 1 country: Australia