Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

Incidence of treatment-emergent adverse events, including treatment-related adverse events.
up to 31 weeks after 1st dosing
Changes from baseline in clinical laboratory assessments, physical examination findings, vital signs, and electrocardiogram (ECG) values.
Laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis. The following 12-lead ECG parameters will be analyzed: ventricular HR, PR interval, QRS duration, QT interval, and QTcF.
up to 31 weeks after 1st dosing

Study Arms (6)

Cohort 1 TE-8105

EXPERIMENTAL

Administered via subcutaneous (SC) injection according to the following step-up schedule: Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks.

Drug: TE-8105 MAD Cohort 1

Cohort 1 Placebo

PLACEBO COMPARATOR

Administered via SC injection matching the Cohort 1 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks).

Drug: Placebo

Cohort 2 TE-8105

EXPERIMENTAL

Administered via SC injection according to the following step-up schedule: Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks.

Interventions

TE-8105 MAD Cohort 1Drug

Administered via SC injection.

Cohort 1 TE-8105

TE-8105 MAD Cohort 2Drug

Administered via SC injection.

Cohort 2 TE-8105

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able to understand the full nature, purpose, and risks of the study and provide written informed consent before starting study procedures.
Body Mass Index (BMI) ≥25 and ≤34.9 kg/m², OR

Sponsors & Collaborators

Immunwork, Inc.
Industrylead

Study Sites (2)

Canopy Clinical Inner West

Leichhardt, New South Wales, 2040, Australia

Canopy Clinical Western Sydney

Penrith, New South Wales, 2750, Australia

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ya-Shan Chuang, PhD

CONTACT

+886-2-2651-2268 yashan.chuang@immunwork.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 24, 2026

First Posted

October 5, 2026

Study Start

October 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

February 2028

You may not qualify if:

An abnormal clinical laboratory test value specified in the protocol.
Previous weight-loss surgery or procedures (e.g., gastric bypass, sleeve gastrectomy, gastric balloon, or intestinal sleeve) within 6 months prior to screening, or planned during the study.
Participation in organized weight-loss programs (e.g., WeightWatchers, Jenny Craig) or meal replacement plans within 30 days prior to screening or planned during the study.
Self-reported weight change of more than 5% in the 6 months prior to randomization or more than 10% in the 12 months prior to screening.
Exposure to any GLP-1 receptor agonist medications within 3 months prior to screening, history of allergic reactions to GLP-1 medications, or lingering effects/rebound weight gain from past GLP-1 treatments.
Use of prescription or over-the-counter medications intended to promote weight loss or that cause weight gain within 3 months prior to randomization.
Use of any diabetes medication other than metformin (e.g., insulin use is excluded).
Diagnosis of Type 1 diabetes, history of diabetic ketoacidosis, or hyperosmolar coma.
Obesity caused by other hormonal disorders (e.g., Cushing syndrome) or rare genetic conditions (e.g., Prader-Willi syndrome).
History or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN 2).
Uncontrolled thyroid disease, unless on a stable thyroid replacement dose for at least 3 months, or subclinical thyroid conditions that may require new treatment during the study.
Severe kidney impairment (eGFR \<30 mL/min/1.73 m² or creatinine clearance \<60 mL/min).
Significant liver disease, acute/chronic hepatitis, elevated liver enzymes (ALT \> 3.0x upper limit of normal, ALP \>1.5x upper limit of normal, or bilirubin \>1.2x upper limit of normal), or fasting triglycerides \> 500 mg/dL.
History of chronic pancreatitis or unexplained acute pancreatitis.
Gastrointestinal disorders (such as severe acid reflux or delayed stomach emptying) that could interfere with drug absorption or study participation.
+17 more criteria

A Study to Investigate the Safety and Efficacy of TE-8105 in Overweight or Obesity Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (6)

Cohort 1 TE-8105

Cohort 1 Placebo

Cohort 2 TE-8105

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Cohort 2 Placebo

Cohort 3 TE-8105

Cohort 3 Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (6)

Cohort 1 TE-8105

Cohort 1 Placebo

Cohort 2 TE-8105

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Cohort 2 Placebo

Cohort 3 TE-8105

Cohort 3 Placebo

You may not qualify if:

Source record

Locations