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

PHASE1RECRUITING

This is a Phase 1, first-in-human, prospective, open-label study to evaluate the safety, tolerability, PK, and PD 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 \[MAD\]).

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Study details:

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 and tolerability of a single dose of 0. 5 mg, 0.

75 mg, 1. 5 mg (or ≤ 2. 5 mg), and 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 12 participants will be assigned to Part B (MAD) (6 participants in each cohort).

Part B is designed to evaluate the safety and tolerability of multiple SC doses of 0. 5 mg (or ≤ 1. 5 mg) and 1.

0 mg (or ≤ 3 mg) 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 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adults who are overweight or obese, do not have diabetes, and who are otherwise healthy, will be recruited.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-06-07

Primary completion: 2025-09-27

Study completion finish: 2025-10-25

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06471530

Intervention or treatment

DRUG: TE-8105 SAD Cohort 1

DRUG: TE-8105 SAD Cohort 2

DRUG: TE-8105 SAD Cohort 3

DRUG: TE-8105 SAD Cohort 4

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

DRUG: TE-8105 MAD Cohort 1

DRUG: TE-8105 MAD Cohort 2

Conditions

• Overweight and Obesity

Condition: Overweight and Obesity
DRUG: TE-8105 SAD Cohort 1 and other drugs
Adelaide, South Australia, Australia
Sponsor: Immunwork, Inc.

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Find a site

Closest Location:

CMAX Clinical Research

Research sites nearby

Select from list below to view details:

CMAX Clinical Research
Adelaide, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A SAD Cohort 1 Each participant will receive TE-8105 administered by subcutaneous injection.	DRUG: TE-8105 SAD Cohort 1 Each participant will receive one dose of TE-8105 0.5 mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.
EXPERIMENTAL: Part A SAD Cohort 2 Each participant will receive TE-8105 administered by subcutaneous injection.	DRUG: TE-8105 SAD Cohort 2 Each participant will receive one dose of TE-8105 0.75 mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.
EXPERIMENTAL: Part A SAD Cohort 3 Each participant will receive TE-8105 administered by subcutaneous injection.	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.
EXPERIMENTAL: Part A SAD Cohort 4 Each participant will receive TE-8105 administered by subcutaneous injection.	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.
EXPERIMENTAL: Part A SAD Cohort 5 (Adaptive Cohort) Each participant will receive TE-8105 administered by subcuteneous injection.	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.
EXPERIMENTAL: Part B MAD Cohort 1 Each participant will receive TE-8105 administered by subcutaneous injection.	DRUG: TE-8105 MAD Cohort 1 Each participant will receive 5 doses of TE-8105 0.5 mg or less than or equal to 1.5 mg injection via SC injection into the abdomen on Day 1 and then Q2W for 5 doses.
EXPERIMENTAL: Part B MAD Cohort 2 Each participant will receive TE-8105 administered by subcutaneous injection.	DRUG: TE-8105 MAD Cohort 2 Each participant will receive 5 doses of TE-8105 1 mg or less than or equal to 3 mg injection via SC injection into the abdomen on Day 1 and then Q2W for 5 doses.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events	Not Specified	SAD: From Screening until Day 43 (End of study) post dose. MAD: From Screening until Day 134 (End of study) post dose
Safety and tolerability of TE-8105 by the incidence of injection site reactions (ISRs)	Not Specified	SAD: On Day 1, Day 2, Day 3, Day 5, Day 8. MAD: On Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64 post dose
Number of participants with change in serum blood parameters	Laboratory assessment includes Hematology, coagulation and serum chemistry.	SAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose
Number of participants with change in urine parameters	Laboratory assessment includes urinalysis	SAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) 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.	SAD: At screening, Day -1, Day 3, Day 8, Day 15 and Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose
Number of participants with changes in 12 lead ECG findings	ECG measurements to include Heart rate, PR, QRS, QT, and QTcF intervals.	SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 92, Day 113, Day 134 (EOS) post dose
Number of participants with changes in temperature	Not Specified	SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]
Number of participants with changes in blood pressure (BP)	Systolic and diastolic BP will be measured	SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]
Number of participants with changes in heart rate (HR)	Not Specified	SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]
Number of participants with changes in respiratory rate (RR)	Not Specified	SAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 5, Day 8, Day 15, Day 43 (EOS) post dose. MAD: At Screening, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS) post dose]

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
PK Parameters : Maximum observed concentration (Cmax)	Not Specified	SAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43 (EOS)
PK Parameters : Maximum observed concentration (Cmax)	Not Specified	MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)
PK Parameters : Time to maximum observed concentration (Tmax)	Not Specified	SAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43 (EOS)
PK Parameters : Time to maximum observed concentration (Tmax)	Not Specified	MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)
PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)	Not Specified	SAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 5, Day 8. Day 11, Day 15, Day 22, Day 29, Day 43 (EOS)
PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)	Not Specified	MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)
PK Parameters : Minimum observed concentration (Cmin)	Not Specified	MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)
PK Parameters : AUC over a dosing interval (AUCτ).	Not Specified	MAD: Predose on Day 1, Post dose on Day 1, Day 2, Day 3, Day 8, Day 15, Day 29, Day 43, Day 57, Day 58, Day 59, Day 64, Day 71, Day 92, Day 113, Day 134 (EOS)

Frequently Asked Questions

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References

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