protocolSection identificationModule nctId: NCT06352437, orgStudyIdInfo id: 1507-0001, secondaryIdInfos id: 2023-508767-79-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1302-5933, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), briefTitle: A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-07-14, completionDateStruct date: 2025-07-14, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 6 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: BI 3034701, interventions name: Placebo matching BI 3034701, outcomesModule primaryOutcomes measure: Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator, secondaryOutcomes measure: Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701, secondaryOutcomes measure: Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701, secondaryOutcomes measure: Part B: Area under the concentration-time curve in plasma over the time interval from 0 to 168 hours (AUC0-168) following multiple doses of BI 3034701, secondaryOutcomes measure: Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False