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

Immunwork, Inc.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Overweight and Obesity

Treatments: Drug: TE-8105 SAD Cohort 3; Drug: TE-8105 MAD Cohort 2; Drug: TE-8105 SAD Cohort 2; Drug: TE-8105 SAD Cohort 5 (Adaptive cohort); Drug: TE-8105 MAD Cohort 1; Drug: TE-8105 SAD Cohort 1; Drug: TE-8105 SAD Cohort 4

Study type: Interventional

Funder types: Industry

Identifiers

NCT06471530

TE-8105-101

Details and patient eligibility

About

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])

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Adults who are overweight or obese, do not have diabetes, and who are otherwise healthy, will be recruited. Main inclusion / exclusion criteria include but are not limited to:

• 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.

Exclusion criteria

• 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.
• Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion.
• Males must use an acceptable, highly effective double contraception from Screening until study completion and must not donate sperm until at least 90 days after the last dose of study drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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44 participants in 7 patient groups

Part A SAD Cohort 1

Experimental group

Description:

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

Treatment:

Drug: TE-8105 SAD Cohort 1

Part A SAD Cohort 2

Experimental group

Description:

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

Treatment:

Drug: TE-8105 SAD Cohort 2

Part A SAD Cohort 3

Experimental group

Description:

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

Treatment:

Drug: TE-8105 SAD Cohort 3

Part A SAD Cohort 4

Experimental group

Description:

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

Treatment:

Drug: TE-8105 SAD Cohort 4

Part A SAD Cohort 5 (Adaptive Cohort)

Experimental group

Description:

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

Treatment:

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

Part B MAD Cohort 1

Experimental group

Description:

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

Treatment:

Drug: TE-8105 MAD Cohort 1

Part B MAD Cohort 2

Experimental group

Description:

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

Treatment:

Drug: TE-8105 MAD Cohort 2