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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
24/06/2024

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, Open-label, Single-Ascending Dose and Multiple-Ascending Dose Study to Investigate the Safety and Tolerability 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 2
Treatment: Drugs - TE-8105 SAD Cohort 3
Treatment: Drugs - TE-8105 SAD Cohort 4
Treatment: Drugs - TE-8105 SAD Cohort 5 (Adaptive cohort)
Treatment: Drugs - TE-8105 MAD Cohort 1
Treatment: Drugs - TE-8105 MAD Cohort 2

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 mg injection via subcutaneous (SC) injection into the abdomen administered on Day 1.

Treatment: Drugs: 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.

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 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.

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 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.

Treatment: Drugs: 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.
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 (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 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
Primary outcome [3] 0 0
Number of participants with change in serum blood parameters
Timepoint [3] 0 0
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
Primary outcome [4] 0 0
Number of participants with change in urine parameters
Timepoint [4] 0 0
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
Primary outcome [5] 0 0
Number of participants with changes in the physical examination findings
Timepoint [5] 0 0
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
Primary outcome [6] 0 0
Number of participants with changes in 12 lead ECG findings
Timepoint [6] 0 0
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
Primary outcome [7] 0 0
Number of participants with changes in temperature
Timepoint [7] 0 0
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]
Primary outcome [8] 0 0
Number of participants with changes in blood pressure (BP)
Timepoint [8] 0 0
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]
Primary outcome [9] 0 0
Number of participants with changes in heart rate (HR)
Timepoint [9] 0 0
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]
Primary outcome [10] 0 0
Number of participants with changes in respiratory rate (RR)
Timepoint [10] 0 0
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 [1] 0 0
PK Parameters : Maximum observed concentration (Cmax)
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
PK Parameters : Maximum observed concentration (Cmax)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
PK Parameters : Time to maximum observed concentration (Tmax)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
PK Parameters : Time to maximum observed concentration (Tmax)
Timepoint [4] 0 0
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)
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 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)
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: 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)
Secondary outcome [7] 0 0
PK Parameters : Minimum observed concentration (Cmin)
Timepoint [7] 0 0
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)
Secondary outcome [8] 0 0
PK Parameters : AUC over a dosing interval (AUCt).
Timepoint [8] 0 0
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)

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
7/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2025
Actual
Sample size
Target
42
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