Placebo matching BI 3034701 / Obesity / Overweight · Phase 2 Trial

A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight

ClinicalTrials.gov · August 20, 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 2 dose-escalation study of BI 3034701 for weight loss in adults with obesity or overweight, currently recruiting. No efficacy or safety results are available in this registry record; the primary endpoint is percentage change in body weight at 42 weeks.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Overweight; age from 18 Years; to 74 Years. Intervention: BI 3034701 treatment group 1; BI 3034701 treatment group 2; BI 3034701 treatment group 3; BI 3034701 treatment group 4; BI 3034701 treatment group 5; BI 3034701 treatment group 6. Compared with: Placebo — Placebo Comparator. n = 300. 55 sites across 6 countries.

Key findings

Safety

No efficacy or safety results reported in this registry record.

Who this may help

Results from this Phase 2 study are not yet available and should not be used to guide clinical practice. Once completed and published, this trial will inform dose selection and efficacy signal for BI 3034701 in obesity, but practice changes would require Phase 3 confirmation.

Plain-language summary

Phase 2 dose-escalation trial with estimated enrollment of 300 participants; no results reported in this registry record, only design and planned outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Percentage change in body weight from baseline at Week 42 [%] (assessed at Baseline and at Week 42.)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Overweight; age from 18 Years; to 74 Years

Sample size300

InterventionBI 3034701 treatment group 1; BI 3034701 treatment group 2; BI 3034701 treatment group 3; BI 3034701 treatment group 4; BI 3034701 treatment group 5; BI 3034701 treatment group 6

ComparatorPlacebo — Placebo Comparator

Setting55 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Estimated enrollment300

Primary outcome measurePercentage change in body weight from baseline at Week 42 [%]

Study duration42 weeks treatment, approximately 10 months total follow-up

Number of study visits15

Probability of active drug allocation>80%

Clinical bottom line

Caveats

No efficacy or safety results reported in this registry record.
Open-label design and unequal randomization (>80% to active treatment) may introduce bias.
Sparse allocation across 7 dose groups limits statistical power per arm.
Exclusion of type 2 diabetes limits generalizability to the broader obesity population.

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

Randomized, placebo-controlled Phase 2 with 7 dose groups; open-label design limits blinding.

Directness

strong

Directly measures percentage body weight change at Week 42, the clinical outcome of interest.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

moderate

Open-label design and unequal allocation (>80% active drug) introduce bias risk.

Sample adequacy

moderate

300 estimated participants across 7 groups; adequate for Phase 2 dose-finding but sparse per arm.

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 (NCT07662122). This is a study registration, not published results. Lead sponsor: Boehringer Ingelheim. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Obesity, Overweight. Interventions: DRUG: BI 3034701; DRUG: Placebo matching BI 3034701. Primary outcome measures: Percentage change in body weight from baseline at Week 42 [%] , Baseline and at Week 42.. Brief summary: This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.

Follow from this

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

Placebo matching BI 3034701ObesityOverweightBI 3034701Boehringer IngelheimNCT07662122