Boehringer registers mass-balance study of obesity drug BI 3034701
The Phase 1 pharmacokinetic study joins three other BI 3034701 trials, including a Phase 2 weight-loss study, as Boehringer builds out its obesity pipeline.
Executive Summary
- Boehringer Ingelheim has registered a Phase 1 study that will track how a single subcutaneous dose of its obesity candidate BI 3034701 is absorbed, distributed, and cleared from the body in healthy men, using a radiolabeled tracer to measure recovery in urine, feces, and exhaled air.
- The study is one of four BI 3034701 trials Boehringer has running or planned, including a Phase 2 study testing whether the drug helps people with obesity or overweight lose weight, and a completed Phase 1 dose-tolerability study, showing the company is developing the drug's clinical pharmacology alongside its efficacy testing rather than starting from scratch.
- The design is a small, open-label pharmacokinetic and mass-balance study, the kind regulators expect to see before or alongside later-stage dosing decisions; it will not generate efficacy or safety data that changes the competitive picture for BI 3034701 in obesity.
The study
The trial, registered with ClinicalTrials.gov on July 16, 2026, will give a single subcutaneous dose of radiolabeled BI 3034701 to healthy men with normal weight or overweight status and track the fraction of radioactivity recovered in urine, feces, and expired air through day 50. That recovery sum is the trial's primary measure, a standard mass-balance endpoint used to characterize how a drug is metabolized and excreted rather than whether it works. Secondary measures cover plasma concentration and exposure of both the parent drug and the radiolabeled tracer through day 22. NCT07708493A Study to Test How BI 3034701 is Taken up and Processed by the Body in Healthy Men With Normal Weight or OverweightNCT07708493
Design and timing
The study is not yet recruiting, plans to enroll 8 participants, and is expected to start July 29, 2026, with a primary completion date of October 14, 2026, an 93-day trial. It uses a single arm with no masking, consistent with an open-label human pharmacokinetic study rather than a controlled efficacy trial. Eligible participants are healthy men aged 18 to 65 with a body mass index of 23.0 to 34.9 kg/m2, screened against standard vital-sign and laboratory criteria. NCT07708493A Study to Test How BI 3034701 is Taken up and Processed by the Body in Healthy Men With Normal Weight or OverweightNCT07708493
Where it sits in the pipeline
BI 3034701 carries three other trials at Boehringer Ingelheim: a Phase 2 study recruiting up to 300 participants to test weight loss in people with obesity or overweight against placebo, with a primary completion date of August 4, 2027; a not-yet-recruiting Phase 1 study of 48 Japanese participants comparing dose tolerability, completing December 22, 2026; and a completed Phase 1 dose-tolerability study of 125 participants that finished October 7, 2025. The mass-balance study registered this week fills in the drug's excretion and metabolism profile while the Phase 2 efficacy trial is already underway.
Sponsor track record
Boehringer Ingelheim has completed 1,639 of 1,777 trials tracked across its global portfolio, a 92% completion rate, and currently runs 70 recruiting and 14 not-yet-recruiting studies across its pipeline. That scale places this single Phase 1 pharmacokinetic study within a routine, well-practiced execution pattern rather than a program under strain.
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