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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Versanis Bio, Inc.
• Treatments: Antibodies, Blocking; Antibodies, Monoclonal

Criteria

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 prior to screening through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method

• 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

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 (e.g., HbA1c ≥ 6.5%) requiring current use of any antidiabetic drugNote: 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 subject's safety or compliance with the protocol