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A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
Phase 1 trial testing BI 3006337 in Non-alcoholic Fatty Liver Disease in 64 participants. Completed in 7 November 2024.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 14 August 2023 |
| Primary completion | 31 October 2024 |
| Estimated completion | 7 November 2024 |
| Sites | 12 locations across United States |
Boehringer Ingelheim — full company profile →
Adults 18 to 75, any sex, with Non-alcoholic Fatty Liver Disease or Obesity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of subjects with drug-related adverse events (AEs) occurring between first administration of trial medication (BI 3006337 or placebo) and end of study (EOS) is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 3006337 50 mg | 9 | |
| BI 3006337 100 mg | 8 | |
| BI 3006337 150 mg | 14 | |
| Placebo | 5 |
Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12 is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 3006337 50 mg | 21000 | ± 57.3 |
| BI 3006337 100 mg | 38800 | ± 81.1 |
| BI 3006337 150 mg | 67100 | ± 50.4 |
Maximum measured concentration of BI 3006337 in serum at steady state (Cmax,ss) after the last dose in Week 12 is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 3006337 50 mg | 312 | ± 87.7 |
| BI 3006337 100 mg | 761 | ± 64.9 |
| BI 3006337 150 mg | 1060 | ± 64.2 |
Time from dosing to the maximum measured concentration of BI 3006337 in serum at steady state (tmax,ss) after the last dose in Week 12 is reported.
| Group | Value | 95% CI |
|---|---|---|
| BI 3006337 50 mg | 13 | 11 – 47 |
| BI 3006337 100 mg | 15 | 3 – 35 |
| BI 3006337 150 mg | 27 | 7 – 47 |
Relative percentage change in liver steatosis from baseline after 12 weeks of treatment is reported. Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF).
| Group | Value | 95% CI |
|---|---|---|
| BI 3006337 50 mg | -13.01 | ± 21.92 |
| BI 3006337 100 mg | -16.59 | ± 40.28 |
| BI 3006337 150 mg | -39.21 | ± 14.73 |
| Placebo | 6.13 | ± 35.24 |
Time frame: From drug administration of BI 3006337 until end of the treatment, up to 99 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BI 3006337 50 mg | BI 3006337 100 mg | BI 3006337 150 mg | Placebo |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Reaction | System | BI 3006337 50 mg | BI 3006337 100 mg | BI 3006337 150 mg | Placebo |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Increased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Injection site erythema | General disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Crystalluria | Renal and urinary disorders | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Injection site pruritus | General disorders | — | — | — | — |
| Vessel puncture site pain | General disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — |
| Ear pain | Ear and labyrinth disorders | — | — | — | — |
| Middle ear effusion | Ear and labyrinth disorders | — | — | — | — |
| Conjunctival haemorrhage | Eye disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Abdominal wall pain | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Eructation | Gastrointestinal disorders | — | — | — | — |
| Faeces soft | Gastrointestinal disorders | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Chest discomfort | General disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Injection site pain | General disorders | — | — | — | — |
Most-reported serious reactions: Non-cardiac chest pain.
Data from ClinicalTrials.gov NCT05970640 adverse events section.
This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease can tolerate. Participants are divided into 4 groups of equal size randomly, which means by chance. Different doses of BI 3006337 are given to participants in each group. Participants in each group receive an injection of either BI 3006337 or placebo once a week. Placebo injections look like BI 3006337 injections but do not contain any medicine. Participants are in the study for about 4 months. During this time, they visit the study site 18 times. Three of the visits include overnight stays at the study site. The doctors check the health of the participants and note any health problems that could have been caused by BI 3006337.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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