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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06471530




Registration number
NCT06471530
Ethics application status
Date submitted
6/06/2024
Date registered
24/06/2024
Date last updated
12/12/2024

Titles & IDs
Public title
A Study to Investigate the Safety and Tolerability of TE-8105 in Overweight/Obese Participants Without Diabetes
Scientific 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
Secondary ID [1] 0 0
TE-8105-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TE-8105 SAD Cohort 1
Treatment: Drugs - TE-8105 SAD Cohort 3
Treatment: Drugs - TE-8105 SAD Cohort 5 (Adaptive cohort)
Treatment: Drugs - TE-8105 MAD Cohort 1
Treatment: Drugs - TE-8105 MAD Cohort 2
Treatment: Drugs - TE-8105 SAD Cohort 2
Treatment: Drugs - TE-8105 SAD Cohort 4

Experimental: Part A SAD Cohort 1 - Each participant will receive TE-8105 administered by subcutaneous injection.

Experimental: Part A SAD Cohort 2 - Each participant will receive TE-8105 administered by subcutaneous injection.

Experimental: Part A SAD Cohort 3 - Each participant will receive TE-8105 administered by subcutaneous injection.

Experimental: Part A SAD Cohort 4 - Each participant will receive TE-8105 administered by subcutaneous injection.

Experimental: Part A SAD Cohort 5 (Adaptive Cohort) - Each participant will receive TE-8105 administered by subcuteneous injection.

Experimental: Part B MAD Cohort 1 - Each participant will receive TE-8105 administered by subcutaneous injection.

Experimental: Part B MAD Cohort 2 - Each participant will receive TE-8105 administered by subcutaneous injection.


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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)

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of TE-8105 by the incidence of treatment-related adverse events
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Safety and tolerability of TE-8105 by the incidence of injection site reactions (ISRs)
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Number of participants with change in serum blood parameters
Timepoint [3] 0 0
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
Primary outcome [4] 0 0
Number of participants with change in urine parameters
Timepoint [4] 0 0
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
Primary outcome [5] 0 0
Number of participants with changes in the physical examination findings
Timepoint [5] 0 0
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
Primary outcome [6] 0 0
Number of participants with changes in 12 lead ECG findings
Timepoint [6] 0 0
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
Primary outcome [7] 0 0
Number of participants with changes in temperature
Timepoint [7] 0 0
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
Primary outcome [8] 0 0
Number of participants with changes in blood pressure (BP)
Timepoint [8] 0 0
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
Primary outcome [9] 0 0
Number of participants with changes in heart rate (HR)
Timepoint [9] 0 0
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
Primary outcome [10] 0 0
Number of participants with changes in respiratory rate (RR)
Timepoint [10] 0 0
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 outcome [1] 0 0
PK Parameters : Maximum observed concentration (Cmax)
Timepoint [1] 0 0
SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
Secondary outcome [2] 0 0
PK Parameters : Maximum observed concentration (Cmax)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
PK Parameters : Time to maximum observed concentration (Tmax)
Timepoint [3] 0 0
SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
Secondary outcome [4] 0 0
PK Parameters : Time to maximum observed concentration (Tmax)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)
Timepoint [5] 0 0
SAD: Predose and post dose on D1, D2, D3, D5, D8, D11, D15, D22, D29, D43 (EOS)
Secondary outcome [6] 0 0
PK Parameters : Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
PK Parameters : Minimum observed concentration (Cmin)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
PK Parameters : AUC over a dosing interval (AUCt).
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Number of participants with change in body weight from baseline with multiple doses of TE-8105.
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Number of participants with change in Body mass index (BMI) from baseline with multiple doses of TE-8105.
Timepoint [10] 0 0
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

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2025
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Immunwork, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ya-Shan Chuang
Address 0 0
Country 0 0
Phone 0 0
+886226512268
Fax 0 0
Email 0 0
yashan.chuang@immunwork.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06471530