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

NCT06471530 | Completed Phase 1 DMC

• 1 other identifier: TE-8105-101
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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 \[MAD\])

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (10)

• Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events

  SAD: From Screening until Day 43 (End of study) post dose. MAD: From Screening until Day 134 in Cohort B1 or Day 155 in Cohort B2 (End of study) post dose

• Safety and tolerability of TE-8105 by the incidence of injection site reactions (ISRs)

  SAD: On D 1, D 2, D 3, D 5, D 8. MAD Cohort B1: On D 1, D 2, D 3, D 8, D 15, D 29, D 43, D 57, D 64 post dose. MAD Cohort B2: On D 1, D2, D 3, D 5, D 8, D 15, D 29, D 43, D 57, D 71, D 85, D 99, D 113, D 117, D 120 and D 127

• Number of participants with change in serum blood parameters

  Laboratory assessment includes Hematology, coagulation and serum chemistry.

  SAD: Scr, D-1, D2, D3, D8, D15, D29, D43 post dose. MAD B1: Scr, D-1, D2, D3, D8, D15, D29, D43, D57, D71, D92, D113, D134 post dose. MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with change in urine parameters

  Laboratory assessment includes urinalysis

  SAD: Scr, D-1, D2, D3, D8, D15, D29, D43 post dose. MAD B1: Scr, D-1, D2, D3, D8, D15, D29, D43, D57, D71, D92, D113, D134 post dose. MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with changes in the physical examination findings

  Complete physical examinations include: general appearance, head, ears, eyes, nose, throat, neck (including thyroid and nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, and other.

  Scr, D-1, D3, D8, D15 and D43 post dose. MAD B1: Scr, D-1, D3, D8, D15, D29, D43, D57, D71, D92, D113, D134 post dose. MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with changes in 12 lead ECG findings

  ECG measurements to include Heart rate, PR, QRS, QT, and QTcF intervals.

  Scr, D-1, D1, D2, D3, D8, D15, D43 post dose. MAD B1: Scr, D-1, D1, D2, D3, D8, D15, D29, D43, D57, D71, D92, D113, D134 post dose. MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with changes in temperature

  SAD: Scr, D-1, D1, D2, D3, D5, D8, D15, D43; MAD B1: Scr, D-1, D1, D2, D3, D8, D15, D29, D43, D57, D64, D71, D92, D113, D134; MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with changes in blood pressure (BP)

  Systolic and diastolic BP will be measured

  SAD: Scr, D-1, D1, D2, D3, D5, D8, D15, D43; MAD B1: Scr, D-1, D1, D2, D3, D8, D15, D29, D43, D57, D64, D71, D92, D113, D134; MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with changes in heart rate (HR)

  SAD: Scr, D-1, D1, D2, D3, D5, D8, D15, D43; MAD B1: Scr, D-1, D1, D2, D3, D8, D15, D29, D43, D57, D64, D71, D92, D113, D134; MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

• Number of participants with changes in respiratory rate (RR)

  SAD: Scr, D-1, D1, D2, D3, D5, D8, D15, D43; MAD B1: Scr, D-1, D1, D2, D3, D8, D15, D29, D43, D57, D64, D71, D92, D113, D134; MAD B2: Scr, D-1, D2, D3, D5, D8, D15, D29, D43, D57, D71, D85, D99, D113, D117, D120, D127, D141 and D155 post dose

Secondary Outcomes (10)

• PK Parameters : Maximum observed concentration (Cmax)

  SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)

• PK Parameters : Maximum observed concentration (Cmax)

  MAD B1: Pre and post dose on D1, D2, D3, D8, D15, D29, D43, D57, D58, D59, D64, D71, D92, D113, D134; MAD B2: Pre and post dose on D1, D2, D3, D5, D8, D15, D29, D43, D57, D58, D71, D85, D99, D113, D114, D115, D117, D120, D127, D141 and D155

• PK Parameters : Time to maximum observed concentration (Tmax)

  SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)

• PK Parameters : Time to maximum observed concentration (Tmax)

  MAD B1: Pre and post dose on D1, D2, D3, D8, D15, D29, D43, D57, D58, D59, D64, D71, D92, D113, D134; MAD B2: Pre and post dose on D1, D2, D3, D5, D8, D15, D29, D43, D57, D58, D71, D85, D99, D113, D114, D115, D117, D120, D127, D141 and D155

• PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)

  SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)

Study Arms (7)

Part A SAD Cohort 1

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcutaneous injection.

Drug: TE-8105 SAD Cohort 1

Part A SAD Cohort 2

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcutaneous injection.

Drug: TE-8105 SAD Cohort 2

Part A SAD Cohort 3

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcutaneous injection.

Drug: TE-8105 SAD Cohort 3

Part A SAD Cohort 4

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcutaneous injection.

Drug: TE-8105 SAD Cohort 4

Part A SAD Cohort 5 (Adaptive Cohort)

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcuteneous injection.

Drug: TE-8105 SAD Cohort 5 (Adaptive cohort)

Part B MAD Cohort 1

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcutaneous injection.

Drug: TE-8105 MAD Cohort 1

Part B MAD Cohort 2

EXPERIMENTAL

Each participant will receive TE-8105 administered by subcutaneous injection.

Drug: TE-8105 MAD Cohort 2

Interventions

TE-8105 SAD Cohort 1 DRUG

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.

Part A SAD Cohort 1

TE-8105 SAD Cohort 3 DRUG

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.

Part A SAD Cohort 3

TE-8105 SAD Cohort 5 (Adaptive cohort) DRUG

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.

Part A SAD Cohort 5 (Adaptive Cohort)

TE-8105 MAD Cohort 1 DRUG

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.

Part B MAD Cohort 1

TE-8105 MAD Cohort 2 DRUG

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)

Part B MAD Cohort 2

TE-8105 SAD Cohort 2 DRUG

Each participant will receive one dose of TE-8105 0.75mg injection via subcutaneous (SC) injection into the abdomen on Day 1.

Part A SAD Cohort 2

TE-8105 SAD Cohort 4 DRUG

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.

Part A SAD Cohort 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Male or female between 18 and 65 years old (both inclusive, at the time of informed consent).
• Have a BMI of ≥ 25 and ≤ 34.9 kg/m² or ≥ 23 and ≤ 32.5 kg/m² for Asian and Aboriginal participants.
• Have a stable body weight, defined as \< 5% change in body weight, in either direction, during the Screening period (Day -28 to Day -1).
• Hemoglobin A1C (HbA1c) \< 6.5%.
• Able and willing to provide written informed consent and any locally required authorization before performing any protocol-related procedures, including screening evaluations.
• Have attended any weight loss treatment or program (e.g., bariatric surgery, medication) within the 3 months prior to Screening, or have scheduled any weight loss treatment or program within the study period.
• Have had any exposure to GLP-1 analogs or other related compounds within the 3 months prior to Screening, or have a history of allergies to glucagon-like peptide-1 (GLP-1) analogs or related compounds.
• Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), a history of ketoacidosis, or hyperosmolar state/coma.
• Anything that the PI considers that would jeopardize the safety of the participant, or prevent complete participation in the study, or compromise the interpretation of study data.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have had a history of chronic pancreatitis or idiopathic acute pancreatitis.
• History of kidney dialysis or renal impairment measured as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m² at Screening.
• Have GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease that impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, except appendectomy) or could be aggravated by GLP-1 analogs.
• Have obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).
• Unwilling to refrain from commencing any new strenuous exercise programs (including weightlifting) from 7 days prior to admission to the study site until 28 days after the final dose.

Sponsors & Collaborators

• Immunwork, Inc.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 24, 2024
• Study Start: July 9, 2024
• Primary Completion: January 3, 2025
• Study Completion: June 7, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

AU (1)