BI 3034701 for Obesity

Not currently recruiting at 72 trial locations
BI
Overseen ByBoehringer Ingelheim
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the experimental medication BI 3034701 can aid weight loss in individuals with obesity or overweight conditions. Participants are divided into seven groups: six receive varying doses of the medication, and one receives a placebo (a look-alike with no active ingredient). Ideal candidates have a BMI of 30 or more, or a BMI of 27 or more with a related health issue, and have struggled to lose weight through dietary changes. Over 10 months, participants will receive injections and dietary counseling, with regular check-ins to monitor weight and health effects. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any anti-obesity or body weight change-inducing medications at least 3 months before screening. If you are on such medications, you will need to stop them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BI 3034701 is generally safe. In earlier studies, both healthy men and individuals with overweight or obesity tolerated it well. Most side effects were mild, and serious ones were rare. This treatment is called a triple agonist because it works in three different ways in the body. It has shown promising results for weight loss, prompting continued study for treating obesity. Although BI 3034701 is not yet approved for any condition, the safety results from earlier studies are encouraging.12345

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity that often include lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide, BI 3034701 offers a fresh approach. Researchers are excited about BI 3034701 because it targets obesity through a potentially new mechanism of action that could improve effectiveness or reduce side effects. It is specifically designed to address metabolic pathways in a novel way, which might lead to better weight management outcomes. This innovative approach has the potential to provide a new option for patients who have not responded well to existing treatments.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown promising results for BI 3034701, a potential treatment for obesity. Research indicates that this medicine targets several pathways in the body to control hunger and improve metabolism. Earlier studies found BI 3034701 to be safe and showed signs of aiding weight loss. The medicine aims to reduce appetite and increase the body's energy efficiency. Initial findings suggest this approach could lead to significant weight loss for many individuals. Participants in this trial will join one of several treatment groups receiving either BI 3034701 or a placebo to further evaluate its effectiveness and safety.12346

Are You a Good Fit for This Trial?

This trial is for adults aged 18–74 who are overweight or have obesity (BMI of at least 30, or at least 27 with a weight-related health issue) and haven't been able to lose weight through diet changes. People with type 2 diabetes cannot join.

Inclusion Criteria

History of at least one self-reported unsuccessful dietary effort to lose body weight
I am able to understand and sign a consent form on my own.
Body mass index (BMI) ≥30 kg/m² at screening, OR BMI ≥27 kg/m² at screening with the presence of at least 1 weight-related complication
See 3 more

Exclusion Criteria

Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) at screening
Body weight increase or decrease of greater than 5% in the 3 months prior to screening
I have taken weight loss or weight-changing medication in the past 3 months.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks, along with counseling to make changes to their diet and exercise regularly

42 weeks
15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular health checks and monitoring of any unwanted effects

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BI 3034701

Trial Overview

The study tests different doses of a new medicine called BI 3034701 versus placebo (a lookalike without active drug) to see if it helps people lose weight. All participants also get advice on healthy eating and exercise over about 10 months.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 3034701 treatment group 6Experimental Treatment1 Intervention
Group II: BI 3034701 treatment group 5Experimental Treatment1 Intervention
Group III: BI 3034701 treatment group 4Experimental Treatment1 Intervention
Group IV: BI 3034701 treatment group 3Experimental Treatment1 Intervention
Group V: BI 3034701 treatment group 2Experimental Treatment1 Intervention
Group VI: BI 3034701 treatment group 1Experimental Treatment1 Intervention
Group VII: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

Citations

Boehringer advances obesity treatment to mid-stage ...

Favorable Phase I profile and encouraging weight loss signals of potential first-in-class triple agonist BI 3034701 supports further ...

A Study to Test How Well Different Doses of BI 3034701 ...

A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity. ClinicalTrials.gov ID NCT06352437.

Boehringer Ingelheim, Gubra Initiate Phase I Clinical Trial ...

Clinical trial for BI 3034701 is expected to evaluate the safety, tolerability, and pharmacokinetics in healthy men and overweight or obese ...

BI-3034701 - Drug Targets, Indications, Patents

Up to 85.1% of survodutide patients lost at least 5% of their weight at 76 weeks, Boehringer said , versus 38.8% in the placebo arm (p<0.0001), ...

Boehringer Ingelheim advances Gubra originated obesity ...

BI 3034701 represents a novel mechanism of action designed to address metabolic diseases through multiple complementary satiety pathways ...

Boehringer Ingelheim advances triple-agonist obesity drug to ...

The Phase 1 trial (NCT06352437) is designed to assess the safety, tolerability, and pharmacokinetics of BI 3034701. It consists of two parts:.