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Monoclonal Antibodies

Bimagrumab + Semaglutide for Obesity

Phase 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable body weight (± 5 kg) within 90 days of screening, and body weight <150 kg
Men and women between 18 and 80 years, inclusive; women of child-bearing potential must meet specific criteria including two negative pregnancy tests and use of intrauterine device with additional contraceptive method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline 48 weeks
Awards & highlights

Study Summary

This trial tests a new drug combo to see if it helps overweight/obese people lose weight safely.

Who is the study for?
Adults aged 18-80 who are overweight or obese (BMI ≥ 30, or BMI ≥ 27 with related health issues like high blood pressure) can join. They must have tried to lose weight before without success and be willing to follow the study's diet and activity plans. Women able to have children need two negative pregnancy tests and must use an IUD plus a barrier method for contraception.Check my eligibility
What is being tested?
The trial is testing Bimagrumab alone or combined with Semaglutide against a placebo in men and women who are overweight or obese. It aims to find out how effective these treatments are at helping participants lose weight, as well as their safety profiles.See study design
What are the potential side effects?
Possible side effects of Bimagrumab may include muscle pain, nausea, diarrhea, and potential allergic reactions. Semaglutide could cause digestive problems like stomach pain, constipation, vomiting, gallbladder issues, low blood sugar levels in people with type 2 diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight has been stable and is under 150 kg.
Select...
I am between 18 and 80 years old. If I can have children, I follow strict birth control measures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in body weight at 48 weeks
Secondary outcome measures
Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)
Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey
Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)
+15 more

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Placebo + semaglutide 2.4 mgExperimental Treatment2 Interventions
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.
Group II: Placebo + semaglutide 1.0 mgExperimental Treatment2 Interventions
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.
Group III: Bimagrumab 30 mg/kg + semaglutide 2.4 mgExperimental Treatment2 Interventions
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.
Group IV: Bimagrumab 30 mg/kg + semaglutide 1.0 mgExperimental Treatment2 Interventions
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.
Group V: Bimagrumab 30 mg/kg + no semaglutideExperimental Treatment1 Intervention
Participants will receive i.v. bimagrumab 30 mg/kg at baseline and at Weeks 4, 16, 28, 40, 52 and 64.
Group VI: Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutideExperimental Treatment1 Intervention
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.
Group VII: Bimagrumab 10 mg/kg + semaglutide 2.4 mgExperimental Treatment2 Interventions
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.
Group VIII: Bimagrumab 10 mg/kg + semaglutide 1.0 mgExperimental Treatment2 Interventions
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.
Group IX: Placebo to bimagrumab 30 mg/kg + no semaglutidePlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimagrumab
2015
Completed Phase 3
~220
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,163 Total Patients Enrolled
52 Trials studying Obesity
40,253 Patients Enrolled for Obesity
Versanis Bio, Inc.Industry Sponsor
1 Previous Clinical Trials
58 Total Patients Enrolled
1 Trials studying Obesity
58 Patients Enrolled for Obesity
Kenneth Attie, MDStudy ChairVersanis Biotechnology
3 Previous Clinical Trials
261 Total Patients Enrolled

Media Library

Bimagrumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05616013 — Phase 2
Obesity Research Study Groups: Bimagrumab 10 mg/kg + semaglutide 2.4 mg, Bimagrumab 30 mg/kg + semaglutide 2.4 mg, Bimagrumab 30 mg/kg + semaglutide 1.0 mg, Bimagrumab 10 mg/kg + semaglutide 1.0 mg, Placebo to bimagrumab 30 mg/kg + no semaglutide, Placebo + semaglutide 1.0 mg, Placebo + semaglutide 2.4 mg, Bimagrumab 10 mg/kg to bimagrumab 30 mg/kg + no semaglutide, Bimagrumab 30 mg/kg + no semaglutide
Obesity Clinical Trial 2023: Bimagrumab Highlights & Side Effects. Trial Name: NCT05616013 — Phase 2
Bimagrumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05616013 — Phase 2
Obesity Patient Testimony for trial: Trial Name: NCT05616013 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruiting efforts still ongoing for this clinical trial?

"Evidenced by clinicaltrials.gov, this medical study is actively seeking out research participants. The trial was first announced on November 16th 2022 and the most recent changes were implemented February 1st 2023."

Answered by AI

Who meets the criteria to enroll in this clinical experiment?

"Eligible participants must meet two criteria: be between 18-80 years old and demonstrate obesity. The trial's recruitment process is ongoing, with an estimated 450 persons sought out for participation."

Answered by AI

Can geriatric patients participate in this research endeavor?

"As per the stated eligibility, those who wish to apply must be aged between 18 and 80. For patients younger than 18, there are 218 studies available, whereas 671 exist for participants over 65 years of age."

Answered by AI

Does the Food and Drug Administration endorse 10 mg/kg bimagrumab?

"10 mg/kg bimagrumab is considered safe, receiving a rating of 2. This can be attributed to the Phase 2 status of this trial, indicating that while data exists confirming safety, there are no studies yet proving efficacy."

Answered by AI

How many sites currently have this experiment underway?

"Currently, the trial is being conducted across 12 sites. These include Cullman, Hialeah and Jacksonville amongst other locations. Selecting a site close to you may be beneficial as it will reduce your travelling burden if participating in this study."

Answered by AI

What is the maximum capacity of individuals taking part in this experiment?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical investigation is actively recruiting patients - having been first shared on November 16th 2022 and most recently updated February 1st 2023. The research requires 450 individuals from 12 different sites in order to proceed."

Answered by AI

What tangible results is this clinical trial expected to yield?

"This 48-week research project aims to observe the variation in waist circumference (WC) from baseline. Secondary outcomes include absolute change of WC (measured with a non-stretchable tape), changes to lean mass via dual energy X-ray absorptiometry, and percent alteration in fat mass by bioelectrical impedance analysis."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Other
Versanis Investigational Site

Why did patients apply to this trial?

I've tryed everything to loss weight. I have tried several diet types and exercise but have been unable to lose weight.
PatientReceived 1 prior treatment
I have tried other ways to lose weight, but nothing has worked. I am very motivated.
PatientReceived 1 prior treatment
I have tried atkins and keto & many other diets, Ozempic n it made me too nauseas and keto.
PatientReceived 2+ prior treatments
I have tried diet and lifestyle modifications and none of them have worked for me. Need to curb my hunger and stop binge eating.
PatientReceived no prior treatments
~28 spots leftby May 2024