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Phase 2Not yet recruiting

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

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

Sponsor
Immunwork, Inc. (Industry)
Enrolment
204 planned
Conditions
Overweight and Obesity
Interventions
TE-8105 MAD Cohort 1; TE-8105 MAD Cohort 2; TE-8105 MAD Cohort 3; Placebo
Ages
adults, older adults
Registry
NCT07857473

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Incidence of treatment-emergent adverse events, including treatment-related adverse events.
  • Changes from baseline in clinical laboratory assessments, physical examination findings, vital signs, and electrocardiogram (ECG) values.

History

  1. Primary completion expected

  2. Expected to start

  3. Registered