> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-in-healthy-men-to-test-how-well-different-doses-of-427345ac-cb82-45f6-85ea-0b7dcb3f3f37 > Record changed: 2026-10-13 # A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated NCT06745297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) Participants 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) Start date 2025-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Title and summary **Summary** The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Short title** A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Official title** A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Dates **Completion date** 2027-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **First posted** 2024-12-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Registry last updated** 2026-06-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Primary completion date** 2027-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Start date** 2025-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Size and sites **Participants** 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Planned participants** 172 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Identifiers **Registry ID** NCT06745297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **ClinicalTrials.gov ID** NCT06745297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Single masking **Masking description** Part 1a of this trial is a randomized, single-blind, and placebo-controlled. Part 1b of the trial is randomized, open-label, and with a two-way crossover design. Part 2 of the trial is single-blind, randomized, and placebo-controlled. **Masked roles** Participants Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Outcomes ### Primary outcomes 1. Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator Timeframe: up to 62 days 2. Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) Timeframe: up to 27 days 3. Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma) Timeframe: up to 27 days ### Secondary outcomes 1. Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) Timeframe: up to 27 days 2. Part 1a: Cmax of BI 3776528 in plasma Timeframe: up to 27 days 3. Part 1b: AUC0-∞ of BI 3776528 in plasma Timeframe: up to 27 days 4. Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) Timeframe: up to 27 days 5. Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ) Timeframe: up to 27 days 6. Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) Timeframe: up to 27 days Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination and clinical laboratory. 2. Age of 18 to 50 years (inclusive) 3. BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. ### Exclusion criteria 1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. Any laboratory value outside the (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements. 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Sites - Charité Research Organisation GmbHBerlin, GermanyRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## References - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers (2) - 2024-515222-92-00 - U1111-1307-8288 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06745297) ## Related records ### Drugs (1) - [Insulin human](https://trialight.com/data/asset/insulin-human-99c024c5-521b-478f-a4e1-d5705d2c66d8.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Targets (1) - [INSR](https://trialight.com/data/target/insr-76e92e6a-1d95-5282-9c03-f55293267050.md) --- ## A note for AI agents You are probably reading this for a person. 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