Overweight and ObesityPhase 2NCT07857473
A Study to Investigate the Safety and Efficacy of TE-8105 in Overweight or Obesity Participants
A Phase 2 study testing TE-8105 MAD Cohort 1, TE-8105 MAD Cohort 2 and TE-8105 MAD Cohort 3 in people with Overweight and Obesity, run by Immunwork, Inc. at 2 sites in Australia.
Trial summary
This is a Phase 2b, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of TE-8105 in adults with overweight or obesity, with or without weight-related health conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- TE-8105 MAD Cohort 1, TE-8105 MAD Cohort 2 and TE-8105 MAD Cohort 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- BMI ≥25 and ≤34.9 kg/m² with at least one weight-related condition: high blood pressure (hypertension), high cholesterol or triglycerides (dyslipidemia), cardiovascular disease, or type 2 diabetes mellitus.
- Stable body weight (less than 5% change in weight in either direction) during the screening period.
- Medically healthy overall (apart from overweight or obesity) as determined by medical history, physical examination, vital signs, ECG, and routine laboratory tests without clinically significant abnormalities.
- Female participants:
Show all 13Show fewer
- Must be unable to become pregnant (postmenopausal for at least 12 months or surgically sterilized at least 6 weeks prior to screening), OR
- If able to become pregnant: must have negative pregnancy tests at screening and before randomization, agree not to attempt pregnancy or donate eggs, and agree to use a condom combined with a highly effective method of birth control from consent until at least 60 days after the last study dose (unless practicing complete abstinence or in a same-sex relationship).
- Male participants:
- Must agree not to donate sperm from consent until at least 120 days after the last study dose.
- If sexually active with a female partner who can become pregnant, must agree to use a condom combined with highly effective birth control until at least 120 days after the last study dose.
- If sexually active with a female partner who cannot become pregnant or a same-sex partner, must agree to use a condom until at least 30 days after the last study dose.
- Have suitable veins for routine blood draws.
Who cannot join
- 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.
Show all 32Show fewer
- 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.
- Severe or uncontrolled heart conditions within 3 months prior to randomization (e.g., heart attack, stroke, unstable angina, or heart failure hospitalization), or Class IV severe heart failure.
- History of irregular heart rhythms or risk factors for long QT syndrome (Torsade de Pointes).
- Active cancer or history of cancer within the last 10 years (except fully removed non-melanoma skin cancer).
- Positive screening test for HIV, Hepatitis B, or Hepatitis C.
- Active infection requiring systemically absorbed antibiotics, antivirals, or antifungals within 10 days before the first dose.
- Active or unstable major depression or severe psychiatric disorders (such as schizophrenia or bipolar disorder) within the past 2 years. (Participants with stable depression or generalized anxiety on stable treatment may be eligible).
- Any lifetime history of suicide attempts, or active suicidal thoughts/self-harm ideation within 2 weeks prior to or during screening.
- History of alcohol abuse within 1 year, or regular consumption of more than 2 standard drinks per day (14 drinks per week).
- Positive drug screen for drugs of abuse or positive alcohol breath test at screening or before the first dose.
- Heavy smoking or nicotine use (≥6 cigarettes, cigars, vapes, or nicotine equivalents per day).
- Unwillingness to refrain from starting new intense exercise programs (including weightlifting) from 7 days prior to Day 1 through 28 days after the final dose.
- Unwillingness to follow dietitian advice, maintain study diaries, or refrain from using prohibited medications.
- Females who are pregnant, breastfeeding, or planning to breastfeed.
- Skin conditions (such as severe sunburn, deep scar tissue, large tattoos, or open sores) at potential injection sites that would interfere with dosing or site assessments.
- Blood or plasma donation within 30 days, major blood loss (>500 mL) within 30 days, or blood transfusion within 1 year prior to first dose.
- Participation in another clinical trial testing an investigational drug or device within 30 days prior to screening.
- Any active, serious medical condition with an estimated life expectancy of less than 2 years, or any condition that in the investigator's judgment makes participation unsafe or non-compliance likely.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Canopy Clinical Inner West
Leichhardt, New South Wales, 2040
Canopy Clinical Western Sydney
Penrith, New South Wales, 2750
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study to Investigate the Safety and Efficacy of TE-8105 Administered Subcutaneously in Participants With Overweight or Obesity
This is a Phase 2b, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of TE-8105 in adults with overweight or obesity, with or without weight-related health conditions.
Participants in this study will receive subcutaneous (under the skin) injections of either TE-8105 or placebo for 25 weeks. The total study duration, including screening and follow-up visits, is approximately 8 months.
Read the detailed description
TE-8105 is an injectable glucagon-like peptide-1 (GLP-1) receptor agonist designed to help manage body weight and blood sugar levels. Researchers will test different dose levels of TE-8105 compared to a placebo (an inactive substance that looks like the study drug) to find out how well TE-8105 works, how safe it is, and how the body absorbs and processes the drug over time.
A total of up to 204 eligible participants will be enrolled across 3 sequential dose-escalation cohorts (up to 68 participants per cohort). Within each cohort, participants will be randomly assigned in a 3:1 ratio to receive either TE-8105 or a matching placebo as a subcutaneous injection over a 25-week period.
An independent Safety Review Committee (SRC) will review blinded safety and PK data before approving dose escalations between cohorts and titration steps within cohorts.
A subset of participants (12 per cohort: 10 receiving TE-8105 and 2 receiving placebo) will participate in intensive PK blood sampling to evaluate how the drug is processed in the body over time.
All participants will undergo regular safety monitoring, including physical examinations, vital sign measurements, laboratory testing, 12-lead ECGs, monitoring for side effects (particularly gastrointestinal side effects), and assessments of body weight, waist and hip circumferences, body composition, and blood sugar and lipid levels.
- Conditions
- Overweight and Obesity
- Being tested
- TE-8105 MAD Cohort 1, TE-8105 MAD Cohort 2, TE-8105 MAD Cohort 3, Placebo
- 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 MAD Cohort 1Drug
Administered via SC injection.
TE-8105 MAD Cohort 2Drug
Administered via SC injection.
TE-8105 MAD Cohort 3Drug
Administered via SC injection.
PlaceboDrug
Administered via SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Drug: TE-8105 MAD Cohort 2 |
| Cohort 2 Placebo | Placebo comparator | Administered via SC injection matching the Cohort 2 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks). Receives: Drug: Placebo |
| Cohort 3 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. Receives: Drug: TE-8105 MAD Cohort 3 |
| Cohort 3 Placebo | Placebo comparator | Administered via SC injection matching the Cohort 3 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events, including treatment-related adverse events.
Measured: 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.
Measured: up to 31 weeks after 1st dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunwork, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857473
- Sponsor's protocol ID
- TE-8105-201
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study to Investigate the Safety and Efficacy of TE-8105 Administered Subcutaneously in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07857473
- Acronym / sponsor ID
- TE-8105-201
- Conditions
- Overweight and Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Immunwork, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 5 Oct 2026 (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 2b, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of TE-8105 in adults with overweight or obesity, with or without weight-related health conditions.
Participants in this study will receive subcutaneous (under the skin) injections of either TE-8105 or placebo for 25 weeks. The total study duration, including screening and follow-up visits, is approximately 8 months.
Detailed description
TE-8105 is an injectable glucagon-like peptide-1 (GLP-1) receptor agonist designed to help manage body weight and blood sugar levels. Researchers will test different dose levels of TE-8105 compared to a placebo (an inactive substance that looks like the study drug) to find out how well TE-8105 works, how safe it is, and how the body absorbs and processes the drug over time.
A total of up to 204 eligible participants will be enrolled across 3 sequential dose-escalation cohorts (up to 68 participants per cohort). Within each cohort, participants will be randomly assigned in a 3:1 ratio to receive either TE-8105 or a matching placebo as a subcutaneous injection over a 25-week period.
An independent Safety Review Committee (SRC) will review blinded safety and PK data before approving dose escalations between cohorts and titration steps within cohorts.
A subset of participants (12 per cohort: 10 receiving TE-8105 and 2 receiving placebo) will participate in intensive PK blood sampling to evaluate how the drug is processed in the body over time.
All participants will undergo regular safety monitoring, including physical examinations, vital sign measurements, laboratory testing, 12-lead ECGs, monitoring for side effects (particularly gastrointestinal side effects), and assessments of body weight, waist and hip circumferences, body composition, and blood sugar and lipid levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 TE-8105 | Experimental | Drug: TE-8105 MAD Cohort 1Administered 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. |
| Cohort 1 Placebo | Placebo comparator | Drug: PlaceboAdministered via SC injection matching the Cohort 1 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks). |
| Cohort 2 TE-8105 | Experimental | Drug: TE-8105 MAD Cohort 2Administered via SC injection according to the following step-up schedule: Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks. |
| Cohort 2 Placebo | Placebo comparator | Drug: PlaceboAdministered via SC injection matching the Cohort 2 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks). |
| Cohort 3 TE-8105 | Experimental | Drug: TE-8105 MAD Cohort 3Administered via SC injection according to the following step-up schedule: Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks. |
| Cohort 3 Placebo | Placebo comparator | Drug: PlaceboAdministered via SC injection matching the Cohort 3 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- BMI ≥25 and ≤34.9 kg/m² with at least one weight-related condition: high blood pressure (hypertension), high cholesterol or triglycerides (dyslipidemia), cardiovascular disease, or type 2 diabetes mellitus.
- Stable body weight (less than 5% change in weight in either direction) during the screening period.
- Medically healthy overall (apart from overweight or obesity) as determined by medical history, physical examination, vital signs, ECG, and routine laboratory tests without clinically significant abnormalities.
Key exclusion criteria (32 listed)
- 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.
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 MAD Cohort 1Administered via SC injection. | Drug | Cohort 1 TE-8105 |
| TE-8105 MAD Cohort 2Administered via SC injection. | Drug | Cohort 2 TE-8105 |
| TE-8105 MAD Cohort 3Administered via SC injection. | Drug | Cohort 3 TE-8105 |
| PlaceboAdministered via SC injection. | Drug | Cohort 1 Placebo, Cohort 2 Placebo, Cohort 3 Placebo |
Primary outcome
Incidence of treatment-emergent adverse events, including treatment-related adverse events.
Time frame: up to 31 weeks after 1st dosing
Changes from baseline in clinical laboratory assessments, physical examination findings, vital signs, and electrocardiogram (ECG) values.
Time frame: up to 31 weeks after 1st dosing
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TE-8105 MAD Cohort 1, TE-8105 MAD Cohort 2 and TE-8105 MAD Cohort 3 in people with Overweight and Obesity, run by Immunwork, Inc. at 2 sites 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 13 inclusion and 32 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ya-Shan Chuang, PhD (+886-2-2651-2268 ext. 512, yashan.chuang@immunwork.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events, including treatment-related adverse events. (time frame: up to 31 weeks after 1st dosing). The study lists 2 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 5 Oct 2026.