Trial · NCT03005288

Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes

NCT03005288, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2020-06-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes. Trials, record NCT03005288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03005288

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes
NCT number: NCT03005288
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Diabetes Mellitus, Type 2
Interventions: BYM338 10 mg/kg, Placebo
First posted: 2016-12-29
Last updated: 2021-01-05
Results first posted: 2020-06-04

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48	Baseline, 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.
Secondary	Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24	Baseline, 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.
Secondary	Change From Baseline in HbA1c at Week 24 and 48	Baseline, Week 24, Week 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.
Secondary	The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336	Day 84, 252, 336 at pre-dose only. Day 168, 308 at pre-dose and 45 mins post-dose	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).
Secondary	Maximum Observed Serum Concentration(Cmax) Derived on Day 1, 168 and 308	Day 1, 168, 308 at pre-dose and 45 mins post-dose	Cmax is the observed maximum plasma concentration following administration (μg/mL).
Secondary	Time to Reach the Maximum Concentration After Drug Administration (Tmax) Derived on Day 168 and 308	Day 1, 168, 308 at pre-dose and 45 mins post-dose	Tmax is the time to reach peak or maximum concentration (h) after the drug administration.
Secondary	Change From Baseline in Body Mass Index (BMI)	Baseline, Week 24, Week 48	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)
Secondary	Change From Baseline in Weight	Baseline, Week 24, Week 48	Body weight was measured to the nearest 0.1 kilogram (kg) in indoor clothing without shoes. A negative change from baseline indicates improvement.
Secondary	Change From Baseline in Lean Body Mass (LBM) Measured by DXA	Baseline, Week 24, Week 48	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. 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.
Secondary	Change From Baseline in Waist Circumference	Baseline, Week 24, Week 52	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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48	Baseline, Week 48	Pharmacodynamic (PD) analysis set	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24	Baseline, Week 24	Pharmacodynamic analysis set	kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in HbA1c at Week 24 and 48	Baseline, Week 24, Week 48	Pharmacodynamic analysis set	percentage change	LEAST_SQUARES_MEAN
SECONDARY	The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336	Day 84, 252, 336 at pre-dose only. Day 168, 308 at pre-dose and 45 mins post-dose	Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338	μg/mL	MEAN
SECONDARY	Maximum Observed Serum Concentration(Cmax) Derived on Day 1, 168 and 308	Day 1, 168, 308 at pre-dose and 45 mins post-dose	Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338	μg/mL	MEAN
SECONDARY	Time to Reach the Maximum Concentration After Drug Administration (Tmax) Derived on Day 168 and 308	Day 1, 168, 308 at pre-dose and 45 mins post-dose	Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338	hr	MEDIAN
SECONDARY	Change From Baseline in Body Mass Index (BMI)	Baseline, Week 24, Week 48	Pharmacodynamic analysis set	Kg/m^2	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weight	Baseline, Week 24, Week 48	Pharmacodynamic analysis set	Kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Lean Body Mass (LBM) Measured by DXA	Baseline, Week 24, Week 48	Pharmacodynamic analysis set	Kg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Waist Circumference	Baseline, Week 24, Week 52	Pharmacodynamic analysis set	cm	LEAST_SQUARES_MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group45

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48	BYM338 10 mg/kg		-7.49	80% Confidence Interval -8.33 to -6.64	kg
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48	Placebo		-0.18	80% Confidence Interval -0.99 to 0.63	kg
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24	BYM338 10 mg/kg		-5.37	80% Confidence Interval -5.96 to -4.78	kg
Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24	Placebo		-0.18	80% Confidence Interval -0.75 to 0.39	kg
Change From Baseline in HbA1c at Week 24 and 48	BYM338 10 mg/kg	week 24	-0.85	80% Confidence Interval -1.06 to -0.64	percentage change
Change From Baseline in HbA1c at Week 24 and 48	Placebo	week 24	0.28	80% Confidence Interval 0.08 to 0.48	percentage change
Change From Baseline in HbA1c at Week 24 and 48	BYM338 10 mg/kg	week 48	-0.76	80% Confidence Interval -1.05 to -0.48	percentage change
Change From Baseline in HbA1c at Week 24 and 48	Placebo	week 48	0.04	80% Confidence Interval -0.23 to 0.31	percentage change
The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336	BYM338 10 mg/kg	Day 84	25.3	Standard Deviation 6.20	μg/mL
The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336	BYM338 10 mg/kg	Day 168	27.5	Standard Deviation 8.37	μg/mL

1 to 10 of 45Source ClinicalTrials.gov

See all 45 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BYM338 10 mg/kg	39
Overall Study	STARTED	Placebo	39
Overall Study	Safety Analysis Set	BYM338 10 mg/kg	37
Overall Study	Safety Analysis Set	Placebo	38
Overall Study	Pharmacokinetics (PK) Analysis Set	BYM338 10 mg/kg	36
Overall Study	Pharmacokinetics (PK) Analysis Set	Placebo	0
Overall Study	Pharmacodynamics (PD) Analysis Set	BYM338 10 mg/kg	36
Overall Study	Pharmacodynamics (PD) Analysis Set	Placebo	36
Overall Study	COMPLETED	BYM338 10 mg/kg	27
Overall Study	COMPLETED	Placebo	31

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events250

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	BYM338 10 mg/kg	3	37
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	38
other	Bundle branch block right	Cardiac disorders	BYM338 10 mg/kg	0	37
other	Bundle branch block right	Cardiac disorders	Placebo	1	38
other	Type V hyperlipidaemia	Congenital, familial and genetic disorders	BYM338 10 mg/kg	1	37
other	Type V hyperlipidaemia	Congenital, familial and genetic disorders	Placebo	0	38
other	Vertigo positional	Ear and labyrinth disorders	BYM338 10 mg/kg	0	37
other	Vertigo positional	Ear and labyrinth disorders	Placebo	1	38
other	Thyroid cyst	Endocrine disorders	BYM338 10 mg/kg	1	37
other	Thyroid cyst	Endocrine disorders	Placebo	0	38

1 to 10 of 250Source ClinicalTrials.gov

See all 250 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BYM338 10 mg/kg	0	37
Total, all-cause mortality	Placebo	0	38
Total, other adverse events	BYM338 10 mg/kg	31	37
Total, other adverse events	Placebo	31	38
Total, serious adverse events	BYM338 10 mg/kg	3	37
Total, serious adverse events	Placebo	3	38

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33439265	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BYM338 10 mg/kg vs Placebo: Immunogenicity Assessed by the Number of Participants Developing Anti-BYM338 Antibodies During the Trial	Trial comparisons
BYM338 10 mg/kg vs Placebo: deaths from any cause	Trial comparisons
BYM338 10 mg/kg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03005288

GET https://conductscience.org/api/trials/v1/NCT03005288/results?page=2

API reference For AI assistants