BI 1356225 / Boehringer Ingelheim - LARVOL DELTA

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: Boehringer Ingelheim | N=60 ➔ 12 | Trial completion date: Feb 2027 ➔ Jul 2026 | Suspended ➔ Terminated | Trial primary completion date: Feb 2027 ➔ Mar 2026; Sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Substance Abuse

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in People With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=60 | Suspended | Sponsor: Boehringer Ingelheim | Recruiting ➔ Suspended

Trial suspension • Substance Abuse

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: May 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Substance Abuse

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Feb 2026 ➔ Jun 2026 | Trial primary completion date: Feb 2026 ➔ May 2026

Trial completion date • Trial primary completion date • Substance Abuse

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial • Substance Abuse

Efficacy and safety of the ghrelin-O-acyltransferase inhibitor BI 1356225 in overweight/obesity: Data from two Phase I, randomised, placebo-controlled studies. (PubMed, Metabolism) - "Treatment with SRDs and MRDs of BI 1356225 was well tolerated by healthy males and subjects with overweight/obesity. BI 1356225 treatment over 28 days reduced AG concentrations and the AG/UAG ratio by >80 %, but no effect was seen on bodyweight, hunger/satiety, control of eating or energy intake. Although, at 4 weeks, the MRD study was fairly short, a reduction in bodyweight would be expected to be evident by this time, suggesting that a reduction of AG via a GOAT inhibitor is not sufficient to induce clinically relevant bodyweight loss."

Journal • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Obesity • Pain

A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight (clinicaltrials.gov) - P1; N=87; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Clinical • Trial completion • Genetic Disorders • Obesity

A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight (clinicaltrials.gov) - P1; N=87; Active, not recruiting; Sponsor: Boehringer Ingelheim; Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women Who Are Overweight or Obese. (clinicaltrials.gov) - P1; N=88; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genetic Disorders • Obesity

A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women Who Are Overweight or Obese. (clinicaltrials.gov) - P1; N=88; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • New P1 trial • Genetic Disorders • Obesity