10 mg/kg bimagrumab for Obesity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Versanis Investigational Site, South Brisbane, AustraliaObesity+2 MoreBimagrumab - Biological
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a new drug combo to see if it helps overweight/obese people lose weight safely.

Eligible Conditions
  • Obesity
  • Overweight or Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Submaximal isometric exercise
1
Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED
1
Risdiplam

Study Objectives

2 Primary · 47 Secondary · Reporting Duration: At baseline, 24 weeks, 48 weeks

At baseline 48 weeks
Absolute change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)
Absolute change from baseline at 48 weeks in lean mass (kg) by dual-energy x-ray absorptiometry (DXA)
Week 24
Change from baseline in WC (cm) at 24 weeks
Percentage of weight loss (kg) due to fat mass or lean mass at 24 weeks
Proportion of participants at 24 weeks with change in Body weight ≥ 5% and ≥ 10%
Proportion of participants at 24 weeks with change in Fat mass ≥ 10% with <5% decrease (or increase) in lean mass
Proportion of participants at 24 weeks with change in fat mass ≥ 5% and ≥ 10%
Proportion of participants at 24 weeks with change in waist circumference ≥ 5 cm
Week 48
Absolute change from baseline at 48 weeks in body fat mass in kilograms (kg)
Absolute change from baseline at 48 weeks in fat mass (kg) by bioelectrical impedance analysis (BIA)
Absolute change from baseline at 48 weeks in visceral adipose tissue (VAT) or trunk fat mass by dual-energy x-ray absorptiometry (DXA)
Absolute change from baseline in WC (cm) at 48 weeks
Change from baseline in WC (cm) at 48 weeks
Change from baseline in body weight at 48 weeks
Percent change from baseline 48 weeks in lean mass (percent lean mass) by bioelectrical impedance analysis (BIA)
Percent change from baseline 48 weeks in lean mass (percent lean mass) by dual energy X-ray absorptiometry (DXA)
Percent change from baseline at 48 weeks in body fat mass in kilograms (kg)
Percent change from baseline at 48 weeks in fat mass (kg) by bioelectrical impedance analysis (BIA)
Percent change from baseline at 48 weeks in visceral adipose tissue (VAT) or trunk fat mass by dual-energy x-ray absorptiometry (DXA)
Percentage of weight loss (kg) due to fat mass or lean mass at 48 weeks
Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA)
Proportion of participants at 48 weeks with change in Body weight ≥ 10%
Proportion of participants at 48 weeks with change in Body weight ≥ 5% and ≥ 10%
Proportion of participants at 48 weeks with change in Fat mass ≥ 10% with <5% decrease (or increase) in lean mass
Proportion of participants at 48 weeks with change in Fat mass ≥ 5% and ≥ 10%
Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15%
Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm
Proportion of patients with change from baseline in BMI categories at 48 weeks
Proportion of patients with change from baseline in WHtR ratio categories at 48 weeks
To assess treatment effects on glucose metabolism in HbA1c
To assess treatment effects on self-reported health status quality of life
To assess treatment effects on self-reported weight-related quality of life
Week 48
Change from baseline at 24 weeks and 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)
Change from baseline in total body weight in kilograms (kg) at 24 weeks and 48 weeks
Change from baseline to 24 weeks and 48 weeks in fat mass (kg) by dual-energy x-ray absorptiometry (DXA)
Percent change from baseline at 24 weeks and 48 weeks in lean mass (percent lean mass) by bioelectrical impedance analysis (BIA)
Percent change from baseline in total body weight in kilograms (kg) at 24 weeks and 48 weeks
Percent change from baseline to 24 weeks and 48 weeks in fat mass (percent body fat) by dual-energy x-ray absorptiometry (DXA)
Week 48
Change from baseline to 24 weeks and 48 weeks in fat mass (kg) by bioelectrical impedance analysis (BIA)
Percent change from baseline to 24 weeks and 48 weeks in fat mass (percent body fat) by bioelectrical impedance analysis (BIA)
Week 48
Tissue Adhesives
Change from baseline to 24 weeks and 48 weeks in lean mass (kg) by dual-energy x-ray absorptiometry (DXA)
Percent change from baseline to 24 weeks and 48 weeks in Visceral Adipose Tissue(VAT)/trunk fat mass by dual-energy x-ray absorptiometry (DXA)
Percent change from baseline to 24 weeks and 48 weeks in lean mass (percent body lean) by dual-energy x-ray absorptiometry (DXA)
Proportion of patients with change from baseline in BMI categories at 24 weeks and 48 weeks
Proportion of patients with change from baseline in WHtR ratio categories at 24 weeks and 48 weeks
To assess treatment effects on glucose metabolism in Homeostasis Model Assessment version 2 (HOMA2)
To assess treatment effects on glucose metabolism in the Quantitative Insulin Sensitivity Check Index (QUICKI)
Baseline and 48 weeks
Safety and tolerability measurements throughout 48 weeks by TEAEs

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Submaximal isometric exercise
1
Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED
2
Risdiplam

Side Effects for

BYM338/Bimagrumab 10 mg/kg
57%Fall
17%Contusion
17%Diarrhoea
11%Skin abrasion
9%Ligament sprain
9%Hypertension
8%Muscle spasms
6%Limb injury
6%Upper respiratory tract infection
6%Musculoskeletal chest pain
6%Pruritus
6%Foot fracture
6%Injury
6%Joint injury
4%Back pain
4%Myalgia
4%Rash
4%Acne
4%Musculoskeletal pain
4%Haematoma
2%Inclusion body myositis
2%Squamous cell carcinoma
2%Headache
2%Ankle fracture
2%Lower limb fracture
2%Joint effusion
2%Haemangioma
2%Pneumonia aspiration
2%Pneumonia
2%Hyperkalaemia
2%Hip fracture
2%Arthralgia
2%Muscular weakness
2%Sepsis
2%Subdural haemorrhage
2%Ulna fracture
2%Pulmonary embolism
2%Respiratory failure
2%Laceration
2%Dizziness
2%Pain in extremity
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02573467) in the BYM338/Bimagrumab 10 mg/kg ARM group. Side effects include: Fall with 57%, Contusion with 17%, Diarrhoea with 17%, Skin abrasion with 11%, Ligament sprain with 9%.

Trial Design

3 Treatment Groups

10 mg/kg bimagrumab
1 of 3
30 mg/kg bimagrumab
1 of 3
Bimagrumab placebo
1 of 3

Experimental Treatment

Non-Treatment Group

450 Total Participants · 3 Treatment Groups

Primary Treatment: 10 mg/kg bimagrumab · Has Placebo Group · Phase 2

10 mg/kg bimagrumab
Biological
Experimental Group · 1 Intervention: Bimagrumab · Intervention Types: Biological
30 mg/kg bimagrumab
Biological
Experimental Group · 1 Intervention: Bimagrumab · Intervention Types: Biological
Bimagrumab placebo
Other
PlaceboComparator Group · 1 Intervention: Bimagrumab Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimagrumab
2015
Completed Phase 3
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline, 24 weeks, 48 weeks

Who is running the clinical trial?

Versanis Bio, Inc.Lead Sponsor
1 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Obesity
58 Patients Enrolled for Obesity
Kenneth Attie, MDStudy ChairVersanis Biotechnology
3 Previous Clinical Trials
261 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
New Jersey100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I have tried several diet types and exercise but have been unable to lose weight"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Are recruiting efforts still ongoing for this clinical trial?

"Evidenced by clinicaltrials.gov, this medical study is actively seeking out research participants. The trial was first announced on November 16th 2022 and the most recent changes were implemented February 1st 2023." - Anonymous Online Contributor

Unverified Answer

Who meets the criteria to enroll in this clinical experiment?

"Eligible participants must meet two criteria: be between 18-80 years old and demonstrate obesity. The trial's recruitment process is ongoing, with an estimated 450 persons sought out for participation." - Anonymous Online Contributor

Unverified Answer

Can geriatric patients participate in this research endeavor?

"As per the stated eligibility, those who wish to apply must be aged between 18 and 80. For patients younger than 18, there are 218 studies available, whereas 671 exist for participants over 65 years of age." - Anonymous Online Contributor

Unverified Answer

Does the Food and Drug Administration endorse 10 mg/kg bimagrumab?

"10 mg/kg bimagrumab is considered safe, receiving a rating of 2. This can be attributed to the Phase 2 status of this trial, indicating that while data exists confirming safety, there are no studies yet proving efficacy." - Anonymous Online Contributor

Unverified Answer

How many sites currently have this experiment underway?

"Currently, the trial is being conducted across 12 sites. These include Cullman, Hialeah and Jacksonville amongst other locations. Selecting a site close to you may be beneficial as it will reduce your travelling burden if participating in this study." - Anonymous Online Contributor

Unverified Answer

What is the maximum capacity of individuals taking part in this experiment?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical investigation is actively recruiting patients - having been first shared on November 16th 2022 and most recently updated February 1st 2023. The research requires 450 individuals from 12 different sites in order to proceed." - Anonymous Online Contributor

Unverified Answer

What tangible results is this clinical trial expected to yield?

"This 48-week research project aims to observe the variation in waist circumference (WC) from baseline. Secondary outcomes include absolute change of WC (measured with a non-stretchable tape), changes to lean mass via dual energy X-ray absorptiometry, and percent alteration in fat mass by bioelectrical impedance analysis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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