Obesity / Overweight / BI 3034701 · Phase 1 Trial

A Study to Test How Well Different and Multiple Doses of BI 3034701 Are Tolerated in People Living With Overweight or Obesity

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 clinical trial registration for BI 3034701, a novel investigational agent, designed to evaluate safety, tolerability, and pharmacokinetics across alternative dose titration strategies in people with overweight or obesity and at least one weight-related comorbidity. No results are reported in this registry record; the study has not yet begun recruitment.

What was studied

Phase 1, Interventional, Randomized, Parallel, Single masking, Treatment purpose. Overweight, Obesity; age from 18 Years; to 74 Years. Intervention: Dose Group 1; Dose Group 2. Compared with: Placebo — Placebo Comparator. n = 35. 1 site: Germany.

Key findings

Safety

Primary endpoint is safety and tolerability; no clinical or efficacy outcomes reported or planned Dose titration strategies and detailed pharmacokinetic results not yet available

Who this may help

This is an early-stage safety trial with no clinical efficacy data. Clinicians should await Phase 2 and later results before considering clinical application.

Plain-language summary

This is a Phase 1 first-in-human safety and tolerability study with no results yet posted; the registry record describes planned conduct only.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator (assessed at Up to 113 days)

DesignPhase 1, Interventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationOverweight, Obesity; age from 18 Years; to 74 Years

Sample size35

InterventionDose Group 1; Dose Group 2

ComparatorPlacebo — Placebo Comparator

Setting1 site: Germany

Reported figures

Quoted from the source exactly as published.

Estimated enrollment35

PhasePHASE 1

Primary outcome assessment periodUp to 113 days

Primary outcome measureOccurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

Clinical bottom line

This is an early-stage safety trial with no clinical efficacy data. Clinicians should await Phase 2 and later results before considering clinical application.

Caveats

Registry record only; no results posted; study has not yet begun recruitment
Sample size (n=35) is typical for Phase 1 but insufficient for efficacy claims
Primary endpoint is safety and tolerability; no clinical or efficacy outcomes reported or planned
Dose titration strategies and detailed pharmacokinetic results not yet available

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1, randomized, placebo-controlled design; appropriate for early safety assessment.

Directness

moderate

Primary endpoint is safety and tolerability; pharmacokinetics secondary; no clinical outcome.

Consistency

insufficient

Registry record only; no results posted; consistency cannot be assessed.

Risk of bias

insufficient

Study not yet recruiting; methods detail insufficient to assess execution or bias risk.

Sample adequacy

limited

Estimated 35 participants; appropriate for Phase 1 feasibility and safety; underpowered for efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07754474). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 35 participants (ESTIMATED). Conditions: Overweight, Obesity. Interventions: DRUG: BI 3034701; DRUG: Placebo. Primary outcome measures: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator , Up to 113 days. Brief summary: The main objectives of this trial are to investigate safety, tolerability of alternative dose titration strategies and pharmacokinetics (PK) of BI 3034701 in participants with overweight / obesity and at least one weight related co-morbidity following subcutaneous administration.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityOverweightBI 3034701NCT07754474Boehringer Ingelheim