A Randomized, Double‑Blind, Placebo‑Controlled Study of Eloralintide (LY3841136) in Adults With Overweight or Obesity
- Trial ID
- 2025-523873-41-00
- Protocol
- J3R-MC-YDAK
- Sponsor
- Eli Lilly & Co.
Trial statistics
Diseases & Conditions
Participants
The study population comprised both male and female patients identified with overweight/obesity. Age eligibility was referenced by internal codes “3” and “4,” indicating a predefined age range, although the exact years were not disclosed. The sponsor did not provide the total number of participants, as the reported subject count was zero. Eligible individuals were selected on the basis of their clinical classification of overweight/obesity, without additional publicly available criteria regarding diet, physical activity, or other lifestyle factors. No further inclusion or exclusion parameters were specified in the available information.
Plans and Procedures
The phase 3, category 1 study of eloralintide (LY3841136) in adults with Obesity employs a randomized, double‑blind, placebo‑controlled parallel‑group design with a planned enrollment period from 12 May 2026 to 10 August 2027; each participant will be followed for approximately 52 weeks after randomization. After providing informed consent, eligible individuals undergo a screening visit to confirm eligibility criteria, followed by a baseline visit during which participants are randomized to active drug or matching placebo and receive the first dose. Subsequent study visits are scheduled at weeks 4, 12, 24, 36, and 48 to assess safety, tolerability, pharmacodynamics, and efficacy outcomes, with additional unscheduled visits permitted for adverse‑event management. The final end‑of‑study visit occurs at week 52, comprising a comprehensive safety assessment and study drug discontinuation. Participants are expected to remain in the trial for the full 12‑month treatment period; however, early termination may occur if a participant experiences a serious adverse event, withdraws consent, fails to comply with protocol‑required procedures, or if the investigator determines that continuation is not in the participant’s best interest.
Treatment
No experimental medication or comparator treatment details are provided in the source documentation.
Efficacy
Efficacy assessments will be conducted in participants diagnosed with overweight or obesity enrolled in this phase 3 clinical trial.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Germany | Recruiting | 12 May 2026 | 115 |

