Overweight and ObesityPhase 1/2NCT06471530
A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes
A Phase 1/2 study testing TE-8105 SAD Cohort 1, TE-8105 SAD Cohort 3 and TE-8105 SAD Cohort 5 (Adaptive cohort) in people with Overweight and Obesity, run by Immunwork, Inc. at 1 site in Australia.
Trial 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]) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- TE-8105 SAD Cohort 1, TE-8105 SAD Cohort 3 and TE-8105 SAD Cohort 5 (Adaptive cohort)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jul 2024to 7 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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])
Read the 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
- Being tested
- TE-8105 SAD Cohort 1, TE-8105 SAD Cohort 3, TE-8105 SAD Cohort 5 (Adaptive cohort), TE-8105 MAD Cohort 1, TE-8105 MAD Cohort 2
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TE-8105 SAD Cohort 1Drug
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.
TE-8105 SAD Cohort 3Drug
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.
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.
TE-8105 MAD Cohort 1Drug
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.
TE-8105 MAD Cohort 2Drug
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)
TE-8105 SAD Cohort 2Drug
Each participant will receive one dose of TE-8105 0.75mg injection via subcutaneous (SC) injection into the abdomen on Day 1.
TE-8105 SAD Cohort 4Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A SAD Cohort 1 | Experimental | Each participant will receive TE-8105 administered by subcutaneous injection. Receives: Drug: TE-8105 SAD Cohort 1 |
| Part A SAD Cohort 2 | Experimental | Each participant will receive TE-8105 administered by subcutaneous injection. Receives: Drug: TE-8105 SAD Cohort 2 |
| Part A SAD Cohort 3 | Experimental | Each participant will receive TE-8105 administered by subcutaneous injection. Receives: Drug: TE-8105 SAD Cohort 3 |
| Part A SAD Cohort 4 | Experimental | Each participant will receive TE-8105 administered by subcutaneous injection. Receives: Drug: TE-8105 SAD Cohort 4 |
| Part A SAD Cohort 5 (Adaptive Cohort) | Experimental | Each participant will receive TE-8105 administered by subcuteneous injection. Receives: Drug: TE-8105 SAD Cohort 5 (Adaptive cohort) |
| Part B MAD Cohort 1 | Experimental | Each participant will receive TE-8105 administered by subcutaneous injection. Receives: Drug: TE-8105 MAD Cohort 1 |
| Part B MAD Cohort 2 | Experimental | Each participant will receive TE-8105 administered by subcutaneous injection. Receives: Drug: TE-8105 MAD Cohort 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
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 blood pressure (BP)
Systolic and diastolic BP will be measured
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)
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 respiratory rate (RR)
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
Secondary outcomes (10)
PK Parameters : Maximum observed concentration (Cmax)
Measured: SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
PK Parameters : Maximum observed concentration (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)
Measured: 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 : Minimum observed concentration (Cmin)
Measured: 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 : AUC over a dosing interval (AUCτ).
Measured: 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
Number of participants with change in body weight from baseline with multiple doses of TE-8105.
Measured: Up to 20 weeks post first dose administration in MAD Cohort B1 and up to 23 weeks post first dose administration in MAD Cohort B2
Number of participants with change in Body mass index (BMI) from baseline with multiple doses of TE-8105.
Measured: Up to 20 weeks post first dose administration in MAD Cohort B1 and up to 23 weeks post first dose administration in MAD Cohort B2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start9 Jul 2024
- Primary completion3 Jan 2025
- Study completion7 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunwork, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471530
- Sponsor's protocol ID
- TE-8105-101
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06471530
- Acronym / sponsor ID
- TE-8105-101
- Conditions
- Overweight and Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Immunwork, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A SAD Cohort 1 | Experimental | Drug: TE-8105 SAD Cohort 1Each participant will receive TE-8105 administered by subcutaneous injection. |
| Part A SAD Cohort 2 | Experimental | Drug: TE-8105 SAD Cohort 2Each participant will receive TE-8105 administered by subcutaneous injection. |
| Part A SAD Cohort 3 | Experimental | Drug: TE-8105 SAD Cohort 3Each participant will receive TE-8105 administered by subcutaneous injection. |
| Part A SAD Cohort 4 | Experimental | Drug: TE-8105 SAD Cohort 4Each participant will receive TE-8105 administered by subcutaneous injection. |
| Part A SAD Cohort 5 (Adaptive Cohort) | Experimental | Drug: TE-8105 SAD Cohort 5 (Adaptive cohort)Each participant will receive TE-8105 administered by subcuteneous injection. |
| Part B MAD Cohort 1 | Experimental | Drug: TE-8105 MAD Cohort 1Each participant will receive TE-8105 administered by subcutaneous injection. |
| Part B MAD Cohort 2 | Experimental | Drug: TE-8105 MAD Cohort 2Each participant will receive TE-8105 administered by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TE-8105 SAD Cohort 1Each 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 | Part A SAD Cohort 1 |
| TE-8105 SAD Cohort 3Each 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 | Part A SAD Cohort 3 |
| 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 | Part A SAD Cohort 5 (Adaptive Cohort) |
| TE-8105 MAD Cohort 1Each 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 | Part B MAD Cohort 1 |
| TE-8105 MAD Cohort 2Each 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 | Part B MAD Cohort 2 |
| TE-8105 SAD Cohort 2Each participant will receive one dose of TE-8105 0.75mg injection via subcutaneous (SC) injection into the abdomen on Day 1. | Drug | Part A SAD Cohort 2 |
| TE-8105 SAD Cohort 4Each 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. | Drug | Part A SAD Cohort 4 |
Primary outcome
Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events
Time frame: 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)
Time frame: 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
Time frame: 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
Laboratory assessment includes Hematology, coagulation and serum chemistry.
Number of participants with change in urine parameters
Time frame: 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
Laboratory assessment includes urinalysis
Number of participants with changes in the physical examination findings
Time frame: 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
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.
Number of participants with changes in 12 lead ECG findings
Time frame: 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
ECG measurements to include Heart rate, PR, QRS, QT, and QTcF intervals.
Number of participants with changes in temperature
Time frame: 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)
Time frame: 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
Systolic and diastolic BP will be measured
Number of participants with changes in heart rate (HR)
Time frame: 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)
Time frame: 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
10 secondary outcomes
PK Parameters : Maximum observed concentration (Cmax)
Time frame: SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
PK Parameters : Maximum observed concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)
Time frame: 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 : Minimum observed concentration (Cmin)
Time frame: 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 : AUC over a dosing interval (AUCτ).
Time frame: 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
Number of participants with change in body weight from baseline with multiple doses of TE-8105.
Time frame: Up to 20 weeks post first dose administration in MAD Cohort B1 and up to 23 weeks post first dose administration in MAD Cohort B2
Number of participants with change in Body mass index (BMI) from baseline with multiple doses of TE-8105.
Time frame: Up to 20 weeks post first dose administration in MAD Cohort B1 and up to 23 weeks post first dose administration in MAD Cohort B2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TE-8105 SAD Cohort 1, TE-8105 SAD Cohort 3 and TE-8105 SAD Cohort 5 (Adaptive cohort) in people with Overweight and Obesity, run by Immunwork, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events (time frame: 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.