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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05616013




Registration number
NCT05616013
Ethics application status
Date submitted
16/10/2022
Date registered
14/11/2022

Titles & IDs
Public title
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
Scientific 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
Secondary ID [1] 0 0
J4Z-MC-GIDA
Secondary ID [2] 0 0
18828
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Obese 0 0
Overweight or Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Bimagrumab
Treatment: Drugs - Semaglutide
Other interventions - Bimagrumab Placebo

Placebo comparator: Placebo to bimagrumab 30 mg/kg + no semaglutide - Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Other: Placebo + semaglutide 1.0 mg - Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Other: Placebo + semaglutide 2.4 mg - Participants will receive i.v. placebo at baseline and at Weeks 4, 16, 28 and 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Experimental: Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutide - Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28 and 40 during the core treatment period and will switch during the extension period to receive bimagrumab 30 mg/kg at Weeks 52 and 64.

Other: Bimagrumab 10 mg/kg + semaglutide 1.0 mg - Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Other: Bimagrumab 10 mg/kg + semaglutide 2.4 mg - Participants will receive i.v. bimagrumab 10 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg weekly per the dose escalation schedule.

Experimental: Bimagrumab 30 mg/kg + no semaglutide - Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64.

Other: Bimagrumab 30 mg/kg + semaglutide 1.0 mg - Participants will receive i.v. bimagrumab 30 mg/kg at baseline, and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 1.0 mg weekly per the dose escalation schedule.

Other: Bimagrumab 30 mg/kg + semaglutide 2.4 mg - Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64, and s.c. semaglutide 2.4 mg per the dose escalation schedule.


Treatment: Other: Bimagrumab
Human monoclonal antibody to the activin receptor type II

Treatment: Drugs: Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist

Other interventions: Bimagrumab Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Body Weight at 48 Weeks
Timepoint [1] 0 0
Baseline, Week 48
Secondary outcome [1] 0 0
Change from Baseline in Waist Circumference (cm) at 48 and 72 Weeks
Timepoint [1] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [2] 0 0
Change from Baseline at 48 and 72 Weeks in Total Body Fat Mass in Kilograms (kg)
Timepoint [2] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [3] 0 0
Change from Baseline at 48 and 72 Weeks in Percent Body Fat
Timepoint [3] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [4] 0 0
Change from Baseline at 48 and 72 Weeks in Visceral Adipose Tissue (VAT), subcutaneous adipose tissue (SAT) and trunk fat mass by dual-energy x-ray absorptiometry (DXA)
Timepoint [4] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [5] 0 0
Percentage of Participants at 48 Weeks with Reduction in Waist Circumference = 5 cm
Timepoint [5] 0 0
At baseline and 48 weeks
Secondary outcome [6] 0 0
Percentage of Participants at 48 Weeks with Reduction in Body Weight = 5%, = 10% and =15%
Timepoint [6] 0 0
At baseline and 48 weeks
Secondary outcome [7] 0 0
Percentage of Participants at 48 Weeks with Reduction in Fat Mass = 5% = 10% = 15% by Dual Energy X-ray Absorptiometry (DXA)
Timepoint [7] 0 0
At baseline and 48 weeks
Secondary outcome [8] 0 0
Percentage of Participants at 48 Weeks with Reduction in Fat Mass = 10% with <5% Decrease (or an Increase) in Lean Mass by Dual Energy X-ray Absorptiometry (DXA)
Timepoint [8] 0 0
At baseline and 48 weeks
Secondary outcome [9] 0 0
Percentage of Weight Loss Due to Fat Mass or Lean Mass at 48 Weeks by Dual Energy X-ray Absorptiometry (DXA)
Timepoint [9] 0 0
At baseline and 48 weeks
Secondary outcome [10] 0 0
Change from Baseline at 48 and 72 Weeks in Fat Mass (kg and %) by Bioelectrical Impedance Analysis (BIA)
Timepoint [10] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [11] 0 0
Change from Baseline at 48 and 72 Weeks in Lean Mass (kg and %) and Appendicular Lean Mass by Dual Energy X-ray Absorptiometry (DXA)
Timepoint [11] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [12] 0 0
Change from Baseline at 48 and 72 Weeks in Lean Mass (kg and %) by Bioelectrical Impedance Analysis (BIA)
Timepoint [12] 0 0
Baseline, Week 48 and Baseline, Week 72
Secondary outcome [13] 0 0
Safety and Tolerability Measurements Throughout 48 Weeks by TEAEs [safety labs, vital signs]
Timepoint [13] 0 0
Baseline and 48 weeks
Secondary outcome [14] 0 0
Percentage of Participants with Change from Baseline in Body Mass Index (BMI) categories at 48 Weeks
Timepoint [14] 0 0
Baseline up to 48 weeks
Secondary outcome [15] 0 0
Percentage of Participants with Change from Baseline in Waist-to-Height Ratio (WHtR ratio) Categories at 48 Weeks
Timepoint [15] 0 0
Baseline up to 48 weeks
Secondary outcome [16] 0 0
Change from Baseline in HbA1c (mmol/mol) at 48 Weeks
Timepoint [16] 0 0
Baseline, 48 weeks
Secondary outcome [17] 0 0
Change from Baseline at 24, 48 and 72 Weeks in Quality of Life Short Form 36 (SF-36) Survey
Timepoint [17] 0 0
Baseline, Week 24; Baseline, Week 48, and Baseline, Week 72
Secondary outcome [18] 0 0
Change from Baseline at 24, 48, and 72 Weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)
Timepoint [18] 0 0
Baseline, Week 24; Baseline, Week 48, and Baseline, Week 72

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 participant's safety or compliance with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
Accrual to date
Final
507
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [3] 0 0
University of The Sunshine Coast Morayfield - Morayfield
Recruitment hospital [4] 0 0
University of the Sunshine Coast Clinical Trial Centre - Sippy Downs
Recruitment hospital [5] 0 0
University of The Sunshine Coast South Brisbane - South Brisbane
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 0 0
Austin Health - Heidelberg Heights
Recruitment hospital [8] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [3] 0 0
4506 - Morayfield
Recruitment postcode(s) [4] 0 0
04556 - Sippy Downs
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [8] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
New Zealand
State/province [8] 0 0
Canterbury
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Christchurch
Country [12] 0 0
New Zealand
State/province [12] 0 0
Hamilton
Country [13] 0 0
New Zealand
State/province [13] 0 0
Nelson
Country [14] 0 0
New Zealand
State/province [14] 0 0
Papatoetoe

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Versanis Bio, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05616013