Clinical trial NCT05616013: Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Obese
Overweight or Obesity
Keywords: bimagrumab
semaglutide
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Versanis Bio, Inc.
First posted: 2022-11-14
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study is designed to have three periods. The 48-week core treatment period has 9 treatment arms, with combinations of 3 semaglutide doses (none, 1.0 mg and 2.4 mg) and 3 bimagrumab doses (0, 10 and 30 mg/kg). The core treatment period is then followed by an open-label 24-week treatment extension period during which participants originally assigned to either placebo or bimagrumab 10 mg/kg will switch to bimagrumab 30 mg/kg. All other treatment assignments will remain the same. The extension period is then followed by a 32-week post-treatment period, during which all study treatments will be withdrawn from all arms.
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Body Weight at 48 Weeks
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Change from Baseline in Waist Circumference (cm) at 48 and 72 Weeks
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: Change from Baseline at 48 and 72 Weeks in Total Body Fat Mass in Kilograms (kg)
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: Change from Baseline at 48 and 72 Weeks in Percent Body Fat
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: 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)
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: Percentage of Participants at 48 Weeks with Reduction in Waist Circumference ≥ 5 cm
timeFrame: At baseline and 48 weeks
measure: Percentage of Participants at 48 Weeks with Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15%
timeFrame: At baseline and 48 weeks
measure: Percentage of Participants at 48 Weeks with Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by Dual Energy X-ray Absorptiometry (DXA)
timeFrame: At baseline and 48 weeks
measure: 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)
timeFrame: At baseline and 48 weeks
measure: Percentage of Weight Loss Due to Fat Mass or Lean Mass at 48 Weeks by Dual Energy X-ray Absorptiometry (DXA)
timeFrame: At baseline and 48 weeks
measure: Change from Baseline at 48 and 72 Weeks in Fat Mass (kg and %) by Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: Change from Baseline at 48 and 72 Weeks in Lean Mass (kg and %) and Appendicular Lean Mass by Dual Energy X-ray Absorptiometry (DXA)
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: Change from Baseline at 48 and 72 Weeks in Lean Mass (kg and %) by Bioelectrical Impedance Analysis (BIA)
timeFrame: Baseline, Week 48 and Baseline, Week 72
measure: Safety and Tolerability Measurements Throughout 48 Weeks by TEAEs [safety labs, vital signs]
timeFrame: Baseline and 48 weeks
measure: Percentage of Participants with Change from Baseline in Body Mass Index (BMI) categories at 48 Weeks
timeFrame: Baseline up to 48 weeks
measure: Percentage of Participants with Change from Baseline in Waist-to-Height Ratio (WHtR ratio) Categories at 48 Weeks
timeFrame: Baseline up to 48 weeks
measure: Change from Baseline in HbA1c (mmol/mol) at 48 Weeks
timeFrame: Baseline, 48 weeks
measure: Change from Baseline at 24, 48 and 72 Weeks in Quality of Life Short Form 36 (SF-36) Survey
timeFrame: Baseline, Week 24; Baseline, Week 48, and Baseline, Week 72
measure: Change from Baseline at 24, 48, and 72 Weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)
timeFrame: Baseline, Week 24; Baseline, Week 48, and Baseline, Week 72
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Columbia
country: United States
facility: SPICA Clinical
state: South Carolina
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research
state: Texas
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Morayfield
country: Australia
facility: University of The Sunshine Coast Morayfield
state: Queensland
city: Sippy Downs
country: Australia
facility: University of the Sunshine Coast Clinical Trial Centre
state: Queensland
city: South Brisbane
country: Australia
facility: University of The Sunshine Coast South Brisbane
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Heidelberg Heights
country: Australia
facility: Austin Health
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
city: Beckenham, Christchurch
country: New Zealand
facility: Southern Clinical Trials Ltd
state: Canterbury
city: Newtown
country: New Zealand
facility: P3 Research
state: Wellington
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research Auckland
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research Christchurch
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials Waikato
city: Nelson
country: New Zealand
facility: Southern Clinical Trials Tasman
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: