Safety, Pharmacokinetics and Efficacy of Bimagrumab in Ov... | NCT03005288

NCT03005288

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BYM338 10 mg/kg	Experimental	Bimagrumab (BYM338) 10 mg/kg up to maximum 1200 mg, every 4 weeks until week 44 (12 doses)	Drug: BYM338 10 mg/kg
Placebo	Placebo Comparator	Placebo, every 4 weeks until week 44 (12 doses)	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BYM338 10 mg/kg	Drug	intravenous infusion every four weeks	BYM338 10 mg/kg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48	Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.	Baseline, Week 48

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24	Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes with HbA1c between 6.5% and 10% at screening with stable treatment for 3 months prior to randomization
On one of the following anti-diabetes regimens with stable treatment for approximately 3 months prior to randomization: 1) metformin monotherapy; 2) DPP4 inhibitor agent monotherapy; 3) combination therapy of metformin and DPP4 inhibitor agent; 4) no anti-diabetes therapy.
Body Mass Index of 28 to 40 kg/m2 at screening
Body weight between 65 and 140 kg at screening

Exclusion Criteria:

Women of child-bearing potential unless they are using highly effective methods of contraception
Diabetes other than Type 2 such as Type 1 diabetes, surgically induced diabetes, "brittle" type 2 diabetes as per investigator judgement, history of severe hypoglycemic episodes in the year preceding screening or hypoglycemic unawareness
History of clinically significant arrythmias, heart failure, unstable angina, myocardial infarction or stroke, coronary artery bypass graft surgery, or percutaneous coronary intervention, deep vein thrombosis/pulmonary embolism, valve disorders or defects, pulmonary hypertension within 6 months of screening or 1 year for drug-eluting stents
Tachycardia
Use of anti-obesity medications, nutritional supplements or over the counter products for weight loss within 3 months of screening
Use of medications known to induce weight gain such as some anti-convulsant and psychotropic medications within 3 months of screening
Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc) or has received anti-HCV treatments within the previous 6 months.
Uncontrolled thyroid disease. Stable euthyroid patients on stable thyroid replacement therapy for at least 3 months of screening are allowed.
Abnormal liver function tests such as SGOT, SGPT, alkaline phosphatase, or serum bilirubin, or abnormal lipase and/or amylase.
Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis).
Uncontrolled depression
Use of skeletal muscle anabolic agents in any form for 3 months prior to screening
Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Anaheim	California	92801	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33439265	Derived	Heymsfield SB, Coleman LA, Miller R, Rooks DS, Laurent D, Petricoul O, Praestgaard J, Swan T, Wade T, Perry RG, Goodpaster BH, Roubenoff R. Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2033457. doi: 10.1001/jamanetworkopen.2020.33457.

Label	URL
A Plain Language Trial Summary is available on novartisclinicaltrials.com	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	BYM338 10 mg/kg	intravenous infusion every four weeks
FG001	Placebo	intravenous infusion every four weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 17, 2019	May 7, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

A total of 78 participants were randomized and were assigned to the respective treatment groups. Of the 78 participants, 3 withdrew from the study prior to dosing due to subject/physician decision. The remaining 75 participants underwent baseline assessments and treatment analysis.

ID	Title	Description
BG000	BYM338 10 mg/kg	intravenous infusion every four weeks
BG001	Placebo	intravenous infusion every four weeks
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00037 BG00138 BG00275

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00060.7± 7.50 BG00160.2± 8.02 BG00260.4± 7.72

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00023 BG00112 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
Black Or African American	BG0006 BG0019 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Hispanic Or Latino	BG00027 BG00125 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48

Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.

Pharmacodynamic (PD) analysis set

Posted

Least Squares Mean

80% Confidence Interval

Baseline, Week 48

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG00036 OG00136

Title

Denominators

Categories

Title	Measurements
	OG000-7.49(-8.33 to -6.64) OG001-0.18(-0.99 to 0.63)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed-Effect Model Repeated Measure		<0.001		Mean Difference (Net)	-7.31			2-Sided	80	-8.48	-6.14					Superiority

Secondary

Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

Baseline, Week 24

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in HbA1c at Week 24 and 48

HbA1c reflects average glucose concentrations over the past 3 months and therefore provides a useful index of the glycemic control of bimagrumab over that time period. It is a standard endpoint used to assess the glycemic efficacy of any anti-diabetic medication. HbA1c is a key glycemic parameter which correlates with reduction of risk of diabetic complications.

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

percentage change

Baseline, Week 24, Week 48

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336

The trough observed analyte concentration (Ctrough) is the concentration that is just prior to the beginning of, or at the end of, a dosing interval (μg/mL).

Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338

Posted

Mean

Standard Deviation

μg/mL

Day 84, 252, 336 at pre-dose only. Day 168, 308 at pre-dose and 45 mins post-dose

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Maximum Observed Serum Concentration(Cmax) Derived on Day 1, 168 and 308

Cmax is the observed maximum plasma concentration following administration (μg/mL).

Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338

Posted

Mean

Standard Deviation

μg/mL

Day 1, 168, 308 at pre-dose and 45 mins post-dose

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Time to Reach the Maximum Concentration After Drug Administration (Tmax) Derived on Day 168 and 308

Tmax is the time to reach peak or maximum concentration (h) after the drug administration.

Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338

Posted

Median

Inter-Quartile Range

Day 1, 168, 308 at pre-dose and 45 mins post-dose

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Mass Index (BMI)

Body Mass Index (BMI) was determined by height and weight measurements at week 24 and 48. A negative change from baseline indicates improvement. BMI was calculated as (Body weight (kg)/ [Height (m)]^2)

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

Kg/m^2

Baseline, Week 24, Week 48

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Weight

Body weight was measured to the nearest 0.1 kilogram (kg) in indoor clothing without shoes. A negative change from baseline indicates improvement.

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

Baseline, Week 24, Week 48

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lean Body Mass (LBM) Measured by DXA

Lean body mass (LBM) is a part of body composition defined as the difference between total body weight and body fat weight. This means that it counts the mass of all organs except body fat, including bones, muscles, blood, skin, and everything else.

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

Baseline, Week 24, Week 48

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants

Secondary

Change From Baseline in Waist Circumference

Waist circumference is the length in cm of the circumference to the nearest 0.1 cm at the level of the umbilicus with the subject in the upright position. A negative change indicates improvement.

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

Baseline, Week 24, Week 52

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Waist to Hip Ratio

Hip circumference was measured at the greatest protrusion of the buttocks. Combined with waist circumference, the waist-to-hip ratio was derived during data analysis.

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

ratio

Baseline, Week 24, Week 52

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Insulin Resistance (HOMA2-IR)

Blood samples were collected to analyze insulin resistance. The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). Higher numbers indicate higher insulin resistance. No established cutoffs are indicating impaired resistance. HOMA2-IR was calculated using an online calculator [https://www.dtu.ox.ac.uk/homacalculator/\].

Pharmacodynamic analysis set

Posted

Least Squares Mean

80% Confidence Interval

Insulin Resistance (IR) Score

Baseline. Week 12, Week 36

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Secondary

Immunogenicity Assessed by the Number of Participants Developing Anti-BYM338 Antibodies During the Trial

Describes the number of participants tested positive for anti-BYM338 antibodies after the start of bimagrumab (BYM338) treatment. A validated bridging enzyme-linked immunosorbent assay (ELISA) was used for the confirmation of the presence of anti-BYM338 antibodies in human serum.

Safety analysis set

Posted

Count of Participants

Participants

392 days

ID	Title	Description
OG000	BYM338 10 mg/kg	intravenous infusion every four weeks
OG001	Placebo	intravenous infusion every four weeks

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BYM338 10 mg/kg	intravenous infusion every four weeks	0	37	3	37	31	37
EG001	Placebo	intravenous infusion every four weeks	0	38	3	38	31	38

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Cellulitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Lipase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0003 affected37 at risk EG0010 affected38 at risk
Bundle branch block right	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Type V hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Thyroid cyst	Endocrine disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Thyroid mass	Endocrine disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Cataract	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Diabetic retinopathy	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Macular oedema	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0011 affected38 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG00015 affected37 at risk EG0014 affected38 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Nausea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0004 affected37 at risk EG0010 affected38 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Toothache	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Vomiting	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0011 affected38 at risk
Asthenia	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Chest pain	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Early satiety	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Fatigue	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Influenza like illness	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Infusion site extravasation	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Non-cardiac chest pain	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Pain	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Peripheral swelling	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Food allergy	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Bronchitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Folliculitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Gastroenteritis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Helicobacter infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Hordeolum	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Influenza	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected38 at risk
Pharyngitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Rhinitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Sialoadenitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Sinusitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Tooth abscess	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Tooth infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0006 affected37 at risk EG0015 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Viral infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Alanine aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Amylase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected38 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Blood creatinine increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Lipase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0004 affected37 at risk EG0012 affected38 at risk
Pancreatic enzymes increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Weight decreased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Weight increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0011 affected38 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0012 affected38 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0012 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG00015 affected37 at risk EG0011 affected38 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0013 affected38 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Cognitive disorder	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Dizziness	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Dysgeusia	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Headache	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0015 affected38 at risk
Paraesthesia	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Sciatica	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Syncope	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected38 at risk
Anxiety	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Insomnia	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Nervousness	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Chromaturia	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Dysuria	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Proteinuria	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Renal cyst	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0012 affected38 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0012 affected38 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Aortic stenosis	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Hypertension	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0003 affected37 at risk EG0011 affected38 at risk
Phlebitis	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk

First MCP Posted Date

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000596367	bimagrumab