A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight (NCT07662122)
A Phase II, Randomised, Double-blind, Parallel-group, 42-week Dose-finding Trial for BI 3034701 Administered Subcutaneously Compared to Placebo in Participants With Obesity or Overweight
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cahaba Research, Inc. - Trussville Location — Birmingham, Alabama
Age range: 18 Years to 74 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (55 Sites)
Showing the first 25 of 55 sites.
- Cahaba Research, Inc. - Trussville Location — Birmingham, Alabama
- Focus Clinical Research — West Hills, California
- Optimus U Corporation-Miami-69452 — Miami, Florida
- Javara-Fayetteville-67354 — Fayetteville, Georgia
- Monroe Biomedical Research - Louisville — Louisville, Kentucky
- Arcturus Healthcare - Troy Internal Medicine Research Division — Troy, Michigan
- StudyMetrix Research, LLC — City of Saint Peters, Missouri
- Clinvest Research LLC — Springfield, Missouri
- Centricity Research - Morehead City — Morehead City, North Carolina
- Accellacare-Wilmington-67123 — Wilmington, North Carolina
- Lillestol Research, LLC — Fargo, North Dakota
- Tribe Clinical Research at Parkside OB-GYN, Greer — Greer, South Carolina
- Texas Diabetes and Endocrinology — Austin, Texas
- South Texas Research Institute - Brownsville — Brownsville, Texas
- South Texas Research Institute-Edinburg-67012 — Edinburg, Texas
- IMA Clinical Research San Antonio — San Antonio, Texas
- Data Point Clinical, LLC — Kirkland, Washington
- Rainier Clinical Research Center — Renton, Washington
- Allegiance Research Specialists — Wauwatosa, Wisconsin
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Southern Adelaide Diabetes and Endocrine Services (SADES) — Oaklands Park, South Australia
- Monash University — Box Hill, Victoria
- Coastal Digestive Health & CDH Research Institute — Queensland,
- Ocean West Research Clinic (Surrey) — Surrey, British Columbia
- Hilltop Medical Clinic — Surrey, British Columbia
📞 Contact the Study Coordinator
Phone: (800) 243-0127
Email: clintriage.rdg@boehringer-ingelheim.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Obesity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.