A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight

Official title

A Phase II, Randomised, Double-blind, Parallel-group, 42-week Dose-finding Trial for BI 3034701 Administered Subcutaneously Compared to Placebo in Participants With Obesity or Overweight

Overview

This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.

Interventions

• Drug BI 3034701
  BI 3034701
• Drug Placebo matching BI 3034701
  Placebo matching BI 3034701

Primary outcome measures

• Percentage change in body weight from baseline at Week 42 [%] [Time frame: Baseline and at Week 42.]

Secondary outcome measures (9)

• Achievement of weight loss of ≥5% of baseline weight at Week 42 [Time frame: Baseline and at Week 42.]
• Achievement of weight loss of ≥10% of baseline weight at Week 42 [Time frame: Baseline and at Week 42.]
• Achievement of weight loss of ≥15% of baseline weight at Week 42 [Time frame: Baseline and at Week 42.]
• Achievement of weight loss of ≥20% of baseline weight at Week 42 [Time frame: Baseline and at Week 42.]
• Absolute change from baseline at Week 42 in body weight [kg] [Time frame: Baseline and at Week 42.]
• Absolute change from baseline at Week 42 in waist circumference [cm] [Time frame: Baseline and at Week 42.]
• Absolute change from baseline at Week 42 in waist-to-height ratio (WHtR) [dimensionless ratio] [Time frame: Baseline and at Week 42.]
• Absolute change from baseline at Week 42 in systolic blood pressure (SBP) [mmHg] [Time frame: Baseline and at Week 42.]
• Absolute change from baseline at Week 42 in diastolic blood pressure (DBP) [mmHg] [Time frame: Baseline and at Week 42.]

Eligibility criteria

Inclusion criteria

• Male or female, age ≥18 to <75 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
• Body mass index (BMI) ≥30 kg/m² at screening, OR BMI ≥27 kg/m² at screening with the presence of at least 1 weight-related complication.
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently
• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the participant information sheet and in protocol.
• In the investigator's opinion, participants are well-motivated, capable, and willing to: Sign the informed consent form (ICF); Learn how to self-inject the investigational medicinal product (IMP)(s) in the abdomen as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP(s)) OR Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and physical activity plan), maintain diaries, complete required questionnaires, and handle the IMP(s) as described in the instructions for use (IFU)

Exclusion criteria

• Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
• Treatment with anti-obesity medication and/or body weight change-inducing medication within 3 months before screening
• Prior surgery of the gastrointestinal (GI) tract that could interfere with body weight including minimally invasive/endoscopic bariatric devices and any bariatric or metabolic surgery involving resection, sleeve gastrectomy, or bypass procedures (e.g. Roux-en-Y, one-anastomosis gastric bypass, duodenal-jejunal bypass sleeve), regardless of whether the device or bypass was removed. The following are allowed: (1) liposuction and/or abdominoplasty, if performed >1 year before screening, (2) lap banding, if the band has been removed >1 year before screening, (3) intragastric balloon, if the balloon has been removed >1 year before screening
• Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
• A Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
• History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose-lowering agent starting within 3 months before screening
• Use of glucagon-like-peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), glucagon receptor (GCGR) or neuropeptide Y receptor 2 (NPY2R) agonists (or the combinations thereof) within 3 months before screening
• Answered "yes" to any of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt, preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening visit up to and including the randomisation visit Further exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 19 centers

• Cahaba Research, Inc. - Trussville Location — Birmingham
• Focus Clinical Research — West Hills
• Optimus U Corporation-Miami-69452 — Miami
• Javara-Fayetteville-67354 — Fayetteville
• Monroe Biomedical Research - Louisville — Louisville
• Arcturus Healthcare - Troy Internal Medicine Research Division — Troy
• StudyMetrix Research, LLC — City of Saint Peters
• Clinvest Research LLC — Springfield
• … and 11 more centers

Canada · 15 centers

• Ocean West Research Clinic (Surrey) — Surrey
• Hilltop Medical Clinic — Surrey
• Dr. M. B. Jones Inc. — Victoria
• Apex Trials (Guelph) — Guelph
• Winterberry Research Inc. — Hamilton
• The Wharton Medical Clinic Clinical Trials Inc. — Hamilton
• Milestone Research Inc. — London
• Stouffville Medical Research Institute Inc. — Stouffville
• … and 7 more centers

China · 8 centers

• Huzhou Central Hospital — Huzhou
• Center Hospital of Jinan — Jinan
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing
• The First Affiliated Hospital of Ningbo University — Ningbo
• First Hospital of Qinhuangdao — Qinhuangdao
• Tianjin Medical University Chu Hisen-I Memorial Hospital — Tianjin
• Yichang Central People's Hospital — Yichang

Australia · 6 centers

• Royal Prince Alfred Hospital — Camperdown
• Logan Hospital — Meadowbrook
• Southern Adelaide Diabetes and Endocrine Services — Oaklands Park
• Monash University — Box Hill
• Austin Health — Heidelberg
• Coastal Digestive Health & CDH Research Institute — Queensland

South Korea · 6 centers

• The Catholic University of Korea, Bucheon St.Mary's Hospital — Bucheon-si
• Eulji University Hospital — Daejeon
• Chosun university hospital — Gwangju
• Seoul National University Bundang Hospital — Seongnam
• Korea University Anam Hospital — Seoul
• Asan Medical Center — Seoul

United Kingdom · 6 centers

• Fylde Coast Clinical Research — Blackpool
• The Garth Surgery — Guisborough
• Velocity Clinical Research, High Wycombe — High Wycombe
• Leicester General Hospital — Leicester
• Linthorpe Surgery — Middlesbrough
• Banbury Cross Health Centre — Oxford

New Zealand · 4 centers

• Momentum Clinical Research Dunedin — Dunedin
• Waitemata Clinical Research — Auckland
• Auckland City Hospital — Grafton / Auckland
• Clinical Trials New Zealand Ltd — Hamilton

Identifiers

NCT: NCT07662122 · 1507-0002 · U1111-1335-5538

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗