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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

July 9, 2024

Primary Completion Date

January 3, 2025

Study Completion Date

June 6, 2025

Conditions
Overweight and Obesity
Interventions
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.

Trial Locations (1)

5000

CMAX Clinical Research, Adelaide

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Immunwork, Inc.

INDUSTRY

NCT06471530 - A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes | Biotech Hunter | Biotech Hunter