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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05616013
Recruitment Status : Recruiting
First Posted : November 14, 2022
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Versanis Bio, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Obesity Obese Overweight or Obesity Biological: Bimagrumab Drug: Semaglutide Other: Bimagrumab Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The study is designed as a factorial of 3 semaglutide doses (none, 1.0 mg and 2.4 mg) and 3 bimagrumab doses (0, 10 and 30 mg/kg).
Masking: Double (Participant, Investigator)
Masking Description:

In regards to bimagrumab and placebo-bimagrumab, the participants, Investigator and Sponsor will be blinded.

Due to semaglutide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind semaglutide.

Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
Actual Study Start Date : November 16, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Placebo Comparator: Bimagrumab placebo
Participants will receive i.v. bimagrumab placebo at baseline, and at Weeks 4, 16, 28 and 40
Other: Bimagrumab Placebo
Placebo

Bimagrumab placebo + 1.0 mg semaglutide
Participants will receive i.v. bimagrumab placebo at baseline, and at Weeks 4, 16, 28 and 40, and 1.0 mg s.c. semaglutide weekly per the dose escalation schedule
Drug: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy
  • Ozempic

Other: Bimagrumab Placebo
Placebo

Bimagrumab placebo + 2.4 mg semaglutide
Participants will receive i.v. bimagrumab placebo at baseline, and at Weeks 4, 16, 28 and 40, and 2.4 mg s.c. semaglutide weekly per the dose escalation schedule
Drug: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy
  • Ozempic

Other: Bimagrumab Placebo
Placebo

Experimental: 10 mg/kg bimagrumab
Participants will receive 10 mg/kg i.v. bimagrumab at baseline, and at Weeks 4, 16, 28 and 40
Biological: Bimagrumab
Human monoclonal antibody to the activin receptor type II

10 mg/kg bimagrumab + 1.0 mg semaglutide
Participants will receive 10 mg/kg i.v. bimagrumab at baseline, and at Weeks 4, 16, 28 and 40, and 1.0 mg s.c. semaglutide weekly per the dose escalation schedule
Biological: Bimagrumab
Human monoclonal antibody to the activin receptor type II

Drug: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy
  • Ozempic

10 mg/kg bimagrumab + 2.4 mg semaglutide
Participants will receive 10 mg/kg i.v. bimagrumab at baseline, and at Weeks 4, 16. 28 and 40, and 2.4 mg s.c. semaglutide weekly per the dose escalation schedule
Biological: Bimagrumab
Human monoclonal antibody to the activin receptor type II

Drug: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy
  • Ozempic

Experimental: 30 mg/kg bimagrumab
Participants will receive 30 mg/kg i.v. bimagrumab at baseline, and at Weeks 4, 16, 28 and 40
Biological: Bimagrumab
Human monoclonal antibody to the activin receptor type II

30 mg/kg bimagrumab + 1.0 mg semaglutide
Participants will receive 30 mg/kg i.v. bimagrumab at baseline, and at Weeks 4, 16. 28, and 40, and 1.0 mg s.c. semaglutide weekly per the dose escalation schedule
Biological: Bimagrumab
Human monoclonal antibody to the activin receptor type II

Drug: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy
  • Ozempic

30 mg/kg bimagrumab + 2.4 mg semaglutide
Participants will receive 30 mg/kg i.v. bimagrumab at baseline, and at Weeks 4, 16, 28 and 40, and 2.4 mg s.c. semaglutide per the dose escalation schedule
Biological: Bimagrumab
Human monoclonal antibody to the activin receptor type II

Drug: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy
  • Ozempic




Primary Outcome Measures :
  1. Change from baseline in body weight at 48 weeks [ Time Frame: At baseline and 48 weeks ]
    Percent change in total body weight will be measured from baseline to 48 weeks


Secondary Outcome Measures :
  1. Absolute change from baseline in WC (cm) at 48 weeks [ Time Frame: At baseline and 48 weeks ]
    Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm).

  2. Absolute change from baseline at 48 weeks in body fat mass in kilograms (kg) [ Time Frame: At baseline and 48 weeks ]
    Body weight will be measured in kilograms (kg) to the nearest 0.1 kg.

  3. Percent change from baseline at 48 weeks in body fat mass in kilograms (kg) [ Time Frame: At baseline and 48 weeks ]
    Body weight will be measured in kilograms (kg) to the nearest 0.1 kg and reported as a percentage.

  4. Absolute change from baseline at 48 weeks in visceral adipose tissue (VAT) or trunk fat mass by dual-energy x-ray absorptiometry (DXA) [ Time Frame: At baseline and 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

  5. Percent change from baseline at 48 weeks in visceral adipose tissue (VAT) or trunk fat mass by dual-energy x-ray absorptiometry (DXA) [ Time Frame: At baseline and 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

  6. Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm [ Time Frame: At baseline and 48 weeks ]
    Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm).

  7. Proportion of participants at 48 weeks with change in Body weight ≥ 10% [ Time Frame: At baseline and 48 weeks ]
    Body weight will be measured in kilograms (kg) to the nearest 0.1 kg.

  8. Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15% [ Time Frame: At baseline and 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess the change in fat mass.

  9. Proportion of participants at 48 weeks with change in Fat mass ≥ 10% with <5% decrease (or increase) in lean mass [ Time Frame: At baseline and 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess body composition.

  10. Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA) [ Time Frame: At baseline and 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

  11. Absolute change from baseline at 48 weeks in fat mass (kg) by bioelectrical impedance analysis (BIA) [ Time Frame: At baseline and 48 weeks ]
    Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition. An estimate of total body water (TBW) is derived by measuring electrical impedance of body tissues, from which fat-free mass (FFM) and body fat (adiposity) are estimated.

  12. Percent change from baseline at 48 weeks in fat mass (kg) by bioelectrical impedance analysis (BIA) [ Time Frame: At baseline and 48 weeks ]
    Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition. An estimate of total body water (TBW) is derived by measuring electrical impedance of body tissues, from which fat-free mass (FFM) and body fat (adiposity) are estimated.

  13. Absolute change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA) [ Time Frame: At baseline 48 weeks ]
    Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition and will be used to assess lean mass (kg)

  14. Absolute change from baseline at 48 weeks in lean mass (kg) by dual-energy x-ray absorptiometry (DXA) [ Time Frame: At baseline 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

  15. Percent change from baseline 48 weeks in lean mass (percent lean mass) by bioelectrical impedance analysis (BIA) [ Time Frame: At baseline and 48 weeks ]
    Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition and will be used to assess percent change in lean mass.

  16. Percent change from baseline 48 weeks in lean mass (percent lean mass) by dual energy X-ray absorptiometry (DXA) [ Time Frame: At baseline and 48 weeks ]
    Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

  17. Safety and tolerability measurements throughout 48 weeks by TEAEs [ Time Frame: Baseline and 48 weeks ]
    Incidence and severity of treatment emergent adverse events (TEAEs)

  18. Proportion of patients with change from baseline in BMI categories at 48 weeks [ Time Frame: At baseline and 48 weeks ]

    BMI categories:

    i. Healthy weight: 18.5 kg/m2 to 24.9 kg/m2 ii. Overweight: 25 kg/m2 to 29.9 kg/m2 iii. Obesity class 1: 30 kg/m2 to 34.9 kg/m2 iv. Obesity class II: 35 kg/m2 to 34.9 kg/m2 v. Obesity class III: ≥ 40 kg/m2


  19. Proportion of patients with change from baseline in WHtR ratio categories at 48 weeks [ Time Frame: At baseline and 48 weeks ]
    WHtR ratio categories: <0.5; 0.5-0.59; ≥0.6

  20. To assess treatment effects on glucose metabolism in HbA1c [ Time Frame: At baseline and 48 weeks ]
    Change from baseline in HbA1c (mmol/mol) at 48 weeks.

  21. To assess treatment effects on self-reported health status quality of life [ Time Frame: At baseline and 48 weeks ]
    Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey. To assess a subject's overall health related quality of life, as well as the physical functioning score. SF- 36 scores range from 0 (worst) to 100 (best)

  22. To assess treatment effects on self-reported weight-related quality of life [ Time Frame: At baseline and 48 weeks ]
    The Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite CT) is a 20-item modified survey instrument that is used to quantitatively assess an individual's perception of how their weight affects their day- to-day life, as well as the physical functioning score. Scores range from 0 (worst) to 100 (best)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 subject's safety or compliance with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05616013


Contacts
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Contact: Kiran Dole, PharmD 6173154410 kiran.dole@versanisbio.com

Locations
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United States, Alabama
Versanis Investigational Site Recruiting
Anniston, Alabama, United States, 36207
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Cullman, Alabama, United States, 35055
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
United States, Florida
Versanis Investigational Site Recruiting
Hialeah, Florida, United States, 33012
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Jacksonville, Florida, United States, 32256
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Not yet recruiting
Lake Worth, Florida, United States, 33461
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
United States, Louisiana
Versanis Investigational Site Not yet recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
United States, New York
Versanis Investigational Site Not yet recruiting
New York, New York, United States, 10021
Contact: Kiran Dole, PharmD       Kiran.Dole@versanis.com   
United States, North Carolina
Versanis Investigational Site Not yet recruiting
Monroe, North Carolina, United States, 28112
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
United States, South Carolina
Versanis Investigational Site Not yet recruiting
Columbia, South Carolina, United States, 29322
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Not yet recruiting
North Charleston, South Carolina, United States, 29405
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
United States, Tennessee
Versanis Investigational Site Not yet recruiting
Memphis, Tennessee, United States, 38119
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
United States, Texas
Versanis Investigational Site Recruiting
Sugar Land, Texas, United States, 77479
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Australia
Versanis Investigational Site Not yet recruiting
Camberwell, Australia
Contact: Kiran Dole, PharmsD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Not yet recruiting
Heidelberg Heights, Australia
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Morayfield, Australia
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Saint Leonards, Australia
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Sippy Downs, Australia
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
South Brisbane, Australia
Contact: Kiran Dole, PharmD       Kiran.Dole@versansibio.com   
Versanis Investigational Site Not yet recruiting
Southport, Australia
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
New Zealand
Versanis Investigational Site Recruiting
Auckland, New Zealand
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Christchurch, New Zealand
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Hamilton, New Zealand
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Recruiting
Nelson, New Zealand
Contact: Kiran Dole, PharmD       Kiran.Dole@versanisbio.com   
Versanis Investigational Site Active, not recruiting
Wellington, New Zealand
Sponsors and Collaborators
Versanis Bio, Inc.
Investigators
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Study Chair: Kenneth Attie, MD Versanis Biotechnology
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Responsible Party: Versanis Bio, Inc.
ClinicalTrials.gov Identifier: NCT05616013    
Other Study ID Numbers: VER201-PH2-031
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Versanis Bio, Inc.:
bimagrumab
semaglutide
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Antibodies, Monoclonal
Antibodies, Blocking
Immunologic Factors
Physiological Effects of Drugs