# Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU

> **NCT01889862** · PHASE3 · COMPLETED · sponsor: **BioMarin Pharmaceutical** · enrollment: 215 (actual)

## Conditions studied

- Phenylketonuria (PKU)

## Interventions

- **DRUG:** BMN165 20mg/day
- **DRUG:** BMN165 40mg/day
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01889862
- **Lead sponsor:** BioMarin Pharmaceutical
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-07-29
- **Primary completion:** 2016-01-13
- **Final completion:** 2019-02-05
- **Target enrollment:** 215 (ACTUAL)
- **Last updated:** 2021-05-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01889862

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01889862, "Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT01889862. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
