Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

Launched by ELI LILLY AND COMPANY · Nov 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two medications, bimagrumab and semaglutide, to see how well they work and how safe they are for adults who are overweight or obese. The goal is to find out if using bimagrumab on its own or with semaglutide can help people lose weight and improve their health. The study is currently active, but it is not recruiting new participants at this time.

To be eligible for this trial, participants need to be between 18 and 80 years old, have a body mass index (BMI) of 30 or more (or 27 with certain health issues), and have tried to lose weight before without success. Women who can become pregnant must use birth control during the study. Participants should also be in good health and able to follow the study rules. If you join the study, you can expect to receive either bimagrumab, semaglutide, or a placebo (a treatment with no active medication) and will need to attend regular visits to monitor your progress and health.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • A written informed consent must be obtained before any study-related assessments are performed.
• * Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:
• • Two negative pregnancy tests (at screening and at randomization, prior to dosing)
• • Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of bimagrumab/placebo i.v.
• • Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
• • Stable body weight (± 5 kg) within 90 days of screening, and body weight \<150 kg
• • Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
• • Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration
• Key Exclusion Criteria:
• • History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (Ozempic® or Wegovy®)
• • Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
• • Treatment with any medication for the indication of obesity within the past 30 days before screening
• • Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
• • Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
• • Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\> 250 mL) within 14 days prior to the first dose
• • Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol