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

NCT05616013 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 18828J4Z-MC-GIDAVER201-PH2-031
• Study Type: interventional
• Target: 507
• Locations: 3 countries
• Sites: 26

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

Conditions

Obesity; Obese; Overweight or Obesity

Keywords

bimagrumab; semaglutide

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight at Week 48

  Least square (LS) Mean was determined by analysis of covariance (ANCOVA) model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm

  Baseline, Week 48

Secondary Outcomes (40)

• Change From Baseline in Waist Circumference at Week 48

  Baseline, Week 48

• Change From Baseline in Waist Circumference at Week 72

  Baseline, Week 72

• Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48

  Baseline, Week 48

• Change From Baseline in Total Body Fat Mass in kg at Week 72

  Baseline, Week 72

• Change From Baseline in Body Fat Percentage at Week 48

  Baseline, Week 48

Study Arms (9)

Placebo

PLACEBO COMPARATOR

Participants received a placebo administered intravenously (IV) at baseline and at weeks 4, 16, 28, and 40 during the core treatment period.

Other: Placebo

Bimagrumab 10 mg/kg

EXPERIMENTAL

Participants received bimagrumab 10 milligrams/kilogram (mg/kg) administered IV at baseline and at weeks 4, 16, 28, and 40 during the core treatment period.

Biological: Bimagrumab

Bimagrumab 30 mg/kg

EXPERIMENTAL

Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40.

Biological: Bimagrumab

Placebo + Semaglutide 1.0 mg

EXPERIMENTAL

Participants received a placebo administered IV at baseline and at Weeks 4, 16, 28, and 40, and 1 milligram (mg) of semaglutide administered subcutaneously (SC) weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg

Drug: Semaglutide; Other: Placebo

Placebo + Semaglutide 2.4 mg

EXPERIMENTAL

Participants received a placebo administered IV at baseline and at weeks 4, 16, 28, and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 48: 2.4 mg.

Drug: Semaglutide; Other: Placebo

Bimagrumab 10 mg/kg + Semaglutide 1.0 mg

EXPERIMENTAL

Participants received bimagrumab 10 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 1 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg.

Biological: Bimagrumab; Drug: Semaglutide

Bimagrumab 10 mg/kg + Semaglutide 2.4 mg

EXPERIMENTAL

Participants received bimagrumab 10 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 48: 2.4 mg.

Biological: Bimagrumab; Drug: Semaglutide

Bimagrumab 30 mg/kg + Semaglutide 1.0 mg

EXPERIMENTAL

Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 1 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg

Biological: Bimagrumab; Drug: Semaglutide

Bimagrumab 30 mg/kg + semaglutide 2.4 mg

EXPERIMENTAL

Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28 and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 48: 2.4 mg.

Biological: Bimagrumab; Drug: Semaglutide

Interventions

Bimagrumab BIOLOGICAL

Human monoclonal antibody to the activin receptor type II

Bimagrumab 10 mg/kg; Bimagrumab 10 mg/kg + Semaglutide 1.0 mg; Bimagrumab 10 mg/kg + Semaglutide 2.4 mg; Bimagrumab 30 mg/kg; Bimagrumab 30 mg/kg + Semaglutide 1.0 mg; Bimagrumab 30 mg/kg + semaglutide 2.4 mg

Semaglutide DRUG

Glucagon-like peptide-1 (GLP-1) receptor agonist

Also known as: Wegovy, Ozempic

Bimagrumab 10 mg/kg + Semaglutide 1.0 mg; Bimagrumab 10 mg/kg + Semaglutide 2.4 mg; Bimagrumab 30 mg/kg + Semaglutide 1.0 mg; Bimagrumab 30 mg/kg + semaglutide 2.4 mg; Placebo + Semaglutide 1.0 mg; Placebo + Semaglutide 2.4 mg

Placebo OTHER

Placebo

Placebo; Placebo + Semaglutide 1.0 mg; Placebo + Semaglutide 2.4 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Versanis Bio, Inc.: collaborator

Study Sites (26)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, 32256, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

SPICA Clinical

Columbia, South Carolina, 29322, United States

Location

Mt. Olympus Medical Research

Sugar Land, Texas, 77479, United States

Location

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

University of The Sunshine Coast Morayfield

Morayfield, Queensland, 4506, Australia

Location

University of the Sunshine Coast Clinical Trial Centre

Sippy Downs, Queensland, 04556, Australia

Location

University of The Sunshine Coast South Brisbane

South Brisbane, Queensland, 4101, Australia

Location

Gold Coast University Hospital

Southport, Queensland, 4215, Australia

Location

Austin Health

Heidelberg Heights, Victoria, 3081, Australia

Location

Emeritus Research

Camberwell, 3124, Australia

Location

Southern Clinical Trials Ltd

Beckenham, Christchurch, Canterbury, 8013, New Zealand

Location

P3 Research

Newtown, Wellington Region, 6242, New Zealand

Location

New Zealand Clinical Research Auckland

Auckland, 1010, New Zealand

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Middlemore Hospital

Auckland, 2025, New Zealand

Location

New Zealand Clinical Research Christchurch

Christchurch, 8011, New Zealand

Location

Lakeland Clinical Trials Waikato

Hamilton, 3200, New Zealand

Location

Southern Clinical Trials Tasman

Nelson, 7011, New Zealand

Location

Related Publications (1)

• Moon S, Choi JW, Park JH, Kim DS, Ahn Y, Kim Y, Kong SH, Oh CM. Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts. J Cachexia Sarcopenia Muscle. 2025 Apr;16(2):e13811. doi: 10.1002/jcsm.13811.

  PMID: 40230053 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

bimagrumab; semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In regard to bimagrumab and placebo-bimagrumab, the participants, Investigator and Sponsor will be blinded. Due to semaglutide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind semaglutide.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 14, 2022
• Study Start: November 16, 2022
• Primary Completion: May 16, 2024
• Study Completion: June 14, 2025
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (10); NZ (8); AU (8)