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Monoclonal Antibodies

BYM338 10 mg/kg for Diabetes

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84, 252, 336 at pre-dose only. day 168, 308 at pre-dose and 45 mins post-dose

Summary

This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients with type 2 diabetes

Eligible Conditions
  • Diabetes
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84, 252, 336 at pre-dose only. day 168, 308 at pre-dose and 45 mins post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84, 252, 336 at pre-dose only. day 168, 308 at pre-dose and 45 mins post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48
Secondary study objectives
Change From Baseline in Body Mass Index (BMI)
Change From Baseline in HbA1c at Week 24 and 48
Change From Baseline in Insulin Resistance (HOMA2-IR)
+9 more

Side effects data

From 2019 Phase 2 trial • 78 Patients • NCT03005288
41%
Diarrhoea
41%
Muscle spasms
16%
Upper respiratory tract infection
11%
Lipase increased
11%
Nausea
8%
Hypertension
8%
Anaemia
5%
Amylase increased
5%
Abdominal pain
5%
Vomiting
5%
Influenza
5%
Decreased appetite
5%
Syncope
5%
Rash
3%
Pancreatic enzymes increased
3%
Acute kidney injury
3%
Menorrhagia
3%
Tooth impacted
3%
Hepatomegaly
3%
Dysgeusia
3%
Proteinuria
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Thyroid mass
3%
Nephrolithiasis
3%
Acne
3%
Blood creatine phosphokinase increased
3%
Musculoskeletal stiffness
3%
Blister
3%
Blood alkaline phosphatase increased
3%
Gamma-glutamyltransferase increased
3%
Cataract
3%
Diabetic retinopathy
3%
Dyspepsia
3%
Frequent bowel movements
3%
Chest pain
3%
Early satiety
3%
Sialoadenitis
3%
Sinusitis
3%
Pain
3%
Macular oedema
3%
Plantar fasciitis
3%
Bronchitis
3%
Dehydration
3%
Sciatica
3%
Hordeolum
3%
Postmenopausal haemorrhage
3%
Type V hyperlipidaemia
3%
Helicobacter infection
3%
Pharyngitis
3%
Urinary tract infection
3%
Viral upper respiratory tract infection
3%
Contusion
3%
Weight increased
3%
Diabetes mellitus
3%
Hyperglycaemia
3%
Arthralgia
3%
Neck mass
3%
Epistaxis
3%
Sinus congestion
3%
Pneumonia
3%
Abdominal pain upper
3%
Pancreatitis
3%
Thyroid cyst
3%
Fatigue
3%
Cholelithiasis
3%
Craniocerebral injury
3%
Muscle fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
BYM338 10 mg/kg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BYM338 10 mg/kgExperimental Treatment1 Intervention
Bimagrumab (BYM338) 10 mg/kg up to maximum 1200 mg, every 4 weeks until week 44 (12 doses)
Group II: PlaceboPlacebo Group1 Intervention
Placebo, every 4 weeks until week 44 (12 doses)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimagrumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,909 Previous Clinical Trials
4,209,991 Total Patients Enrolled
5 Trials studying Diabetes
1,104 Patients Enrolled for Diabetes
~9 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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