Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05616013
• Other study ID #: 18828
• Secondary ID: J4Z-MC-GIDAVER20
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 16, 2022
• Est. completion date: June 17, 2025

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

Description:

This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 507
• Est. completion date: June 17, 2025
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• 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 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

Related Conditions & MeSH terms

• Obese
• Obesity
• Overweight
• Overweight or Obesity

Intervention

Biological:
• Bimagrumab
Human monoclonal antibody to the activin receptor type II

Drug:
• Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist

Other:
• Bimagrumab Placebo
Placebo

Locations

Country	Name	City	State
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	Austin Health	Heidelberg West	Victoria
Australia	University of The Sunshine Coast Morayfield	Morayfield	Queensland
Australia	Royal North Shore Hospital	Saint Leonards	New South Wales
Australia	University of the Sunshine Coast Clinical Trial Centre	Sippy Downs	Queensland
Australia	Gold Coast University Hospital	South Brisbane	Queensland
Australia	University of The Sunshine Coast South Brisbane	South Brisbane	Queensland
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	New Zealand Clinical Research Auckland	Christchurch	Auckland
New Zealand	New Zealand Clinical Research Christchurch	Christchurch
New Zealand	Southern Clinical Trials Ltd	Christchurch	Canterbury
New Zealand	Lakeland Clinical Trials Waikato	Hamilton
New Zealand	Southern Clinical Trials Tasman	Nelson
New Zealand	P3 Research	Newtown	Wellington
New Zealand	Middlemore Clinical Trials	Papatoetoe
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	SPICA Clinical	Columbia	South Carolina
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Indago Research & Health Center, Inc	Hialeah	Florida
United States	Clinical Neuroscience Solutions Inc	Jacksonville	Florida
United States	Altus Research	Lake Worth	Florida
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Weill Cornell Medical College	New York	New York
United States	Mt. Olympus Medical Research	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Versanis Bio, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body weight at 48 weeks	Change in total body weight will be measured from baseline to 48 weeks	At baseline and 48 weeks
Secondary	Change from baseline in waist circumference (cm) at 48 weeks	Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm).	At baseline and 48 weeks
Secondary	Change from baseline at 48 weeks in total body fat mass in kilograms (kg)	Fat mass will be obtained by dual-energy x-ray absorptiometry (DXA) Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.	At baseline and 48 weeks
Secondary	Change from baseline at 48 weeks in percent body fat	Percent body fat will be obtained by dual-energy x-ray absorptiometry (DXA) Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.	At baseline and 48 weeks
Secondary	Change from baseline at 48 weeks in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and trunk fat mass by dual-energy x-ray absorptiometry (DXA)	Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.	At baseline and 48 weeks
Secondary	Proportion of participants at 48 weeks with change in waist circumference = 5 cm	Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm).	At baseline and 48 weeks
Secondary	Proportion of participants at 48 weeks with change in Body weight = 5%, = 10% and =15%	Body weight will be measured in kilograms (kg) to the nearest 0.1 kg.	At baseline and 48 weeks
Secondary	Proportion of participants at 48 weeks with change in Fat mass = 5% = 10% = 15% by Dual energy X-ray absorptiometry (DXA)	Dual energy X-ray absorptiometry (DXA) will be used to assess the changes in body composition.	At baseline and 48 weeks
Secondary	Proportion of participants at 48 weeks with change in Fat mass = 10% with <5% decrease (or and increase) in lean mass by Dual energy X-ray absorptiometry (DXA)	Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.	At baseline and 48 weeks
Secondary	Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA)	Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.	At baseline and 48 weeks
Secondary	Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)	Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition.	At baseline and 48 weeks
Secondary	Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA)	Dual-energy x-ray absorptiometry (DXA) will be used to assess changes in body composition.	At baseline 48 weeks
Secondary	Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)	Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition.	At baseline 48 weeks
Secondary	Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]	Incidence and severity of treatment emergent adverse events (TEAEs)	Baseline and 48 weeks
Secondary	Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks	BMI categories: i. Healthy weight: 18.5 kg/m2 to 24.9 kg/m2 ii. Overweight: 25 kg/m2 to 29.9 kg/m2 iii. Obesity class 1: 30 kg/m2 to 34.9 kg/m2 iv. Obesity class II: 35 kg/m2 to 39.9 kg/m2 v. Obesity class III: = 40 kg/m2	At baseline and 48 weeks
Secondary	Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks	WHtR ratio categories: <0.5; 0.5-0.59; =0.6	At baseline and 48 weeks
Secondary	Change from baseline in HbA1c (mmol/mol) at 48 weeks	To assess treatment effects on glucose metabolism and HbA1c.	At baseline and 48 weeks
Secondary	Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey	Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey. To assess a subject's overall health related quality of life, as well as the physical functioning score. SF- 36 scores range from 0 (worst) to 100 (best)	At baseline and 48 weeks
Secondary	Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)	Change from baseline in IWQOL-Lite CT. IWQOL-Lite CT is a 20-item modified survey instrument that is used to quantitatively assess an individual's perception of how their weight affects their day- to-day life, as well as the physical function score. Scores range from 0 (worst) to 100 (best)	At baseline and 48 weeks