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

ConditionOverweight and Obesity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorImmunwork, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TE-8105 MAD Cohort 1

    Drug

    Administered via SC injection.

  • TE-8105 MAD Cohort 2

    Drug

    Administered via SC injection.

  • TE-8105 MAD Cohort 3

    Drug

    Administered via SC injection.

  • Placebo

    Drug

    Administered via SC injection.

Treatment groups

204 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Cohort 1 TE-8105Experimental treatment 1 intervention
Group B: Cohort 1 PlaceboPlacebo comparator 1 intervention
Group C: Cohort 2 TE-8105Experimental treatment 1 intervention
Group D: Cohort 2 PlaceboPlacebo comparator 1 intervention
Group E: Cohort 3 TE-8105Experimental treatment 1 intervention
Group F: Cohort 3 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events, including treatment-related adverse events.

Time frame
up to 31 weeks after 1st dosing
2

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.

Time frame
up to 31 weeks after 1st dosing

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunwork, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: