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

Lilly

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight or Obesity; Obese; Obesity

Treatments: Drug: Semaglutide; Biological: Bimagrumab; Other: Bimagrumab Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05616013

18828

VER201-PH2-031

J4Z-MC-GIDA (Other Identifier)

Details and patient eligibility

About

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

Full description

This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Enrollment: 507 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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507 participants in 9 patient groups, including a placebo group

Placebo to bimagrumab 30 mg/kg + no semaglutide

Placebo Comparator group

Description:

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Treatment:

Other: Bimagrumab Placebo

Biological: Bimagrumab

Placebo + semaglutide 1.0 mg

Other group

Description:

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Treatment:

Other: Bimagrumab Placebo

Drug: Semaglutide

Placebo + semaglutide 2.4 mg

Other group

Description:

Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Treatment:

Other: Bimagrumab Placebo

Drug: Semaglutide

Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutide

Experimental group

Description:

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Treatment:

Biological: Bimagrumab

Bimagrumab 10 mg/kg + semaglutide 1.0 mg

Other group

Description:

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Treatment:

Biological: Bimagrumab

Drug: Semaglutide

Bimagrumab 10 mg/kg + semaglutide 2.4 mg

Other group

Description:

Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Treatment:

Biological: Bimagrumab

Drug: Semaglutide

Bimagrumab 30 mg/kg + no semaglutide

Experimental group

Description:

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64.

Treatment:

Biological: Bimagrumab

Bimagrumab 30 mg/kg + semaglutide 1.0 mg

Other group

Description:

Participants will receive i.v. bimagrumab 30 mg/kg at baseline, and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Treatment:

Biological: Bimagrumab

Drug: Semaglutide

Bimagrumab 30 mg/kg + semaglutide 2.4 mg

Other group

Description:

Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg per the dose escalation schedule.

Treatment:

Biological: Bimagrumab

Drug: Semaglutide