Bimagrumab + Tirzepatide for Healthy Subjects

Overseen By This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Pancreatitis, Hepatitis, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have taken weight loss medications or remedies in the past 3 months.

What makes the drug Bimagrumab + Tirzepatide unique?

Bimagrumab + Tirzepatide is unique because it combines two different mechanisms: Bimagrumab, which is known for its ability to increase muscle mass, and Tirzepatide, which is used for managing blood sugar levels and weight. This combination could offer a novel approach by addressing both muscle growth and metabolic health simultaneously, unlike standard treatments that typically focus on one aspect. ^{1 2 3 4 5}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy individuals with a BMI of 22.0 to 30.0 kg/m2 who haven't had significant weight changes or taken weight loss remedies in the last 3 months. They shouldn't have a history of pancreatitis, hepatitis, or uncontrolled high blood pressure.

Inclusion Criteria

Are considered healthy as determined by medical evaluation including medical history and physical examination

Have a body mass index (BMI) within the range of 22.0 to 30.0 kilograms per square meter (kg/m2), inclusive

Exclusion Criteria

Have a self-reported increase or decrease in body weight, greater than 5 kilograms (kg), within 3 months prior to screening

I have or had pancreatitis or hepatitis.

I have used weight loss medications or remedies in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bimagrumab alone or with tirzepatide for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimagrumab
• Tirzepatide

Trial Overview The study tests how bimagrumab alone and combined with tirzepatide affects the body's concentration levels over approximately 4.5 months, including screening and follow-up phases.

How Is the Trial Designed?

Group I: Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation) Experimental Treatment 1 Intervention

Participants will receive bimagrumab with tirzepatide SC for 4 weeks

Group II: Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration) Experimental Treatment 2 Interventions

Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks

Group III: Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation) Experimental Treatment 1 Intervention

Participants will receive a single dose of bimagrumab with tirzepatide SC

Group IV: Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration) Experimental Treatment 2 Interventions

Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC

Group V: Bimagrumab Dose 1 Reference Material Experimental Treatment 1 Intervention

Participants will receive a single dose of bimagrumab subcutaneously (SC)

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

The combination of vibostolimab and pembrolizumab is well tolerated by patients, indicating a favorable safety profile for this treatment regimen.

This combination therapy demonstrates antitumor activity, suggesting it may be an effective option for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]

Adagrasib combined with pembrolizumab shows promising efficacy for patients with newly diagnosed non-small cell lung cancer with a KRASG12C mutation, achieving overall response rates of 49% and 57% in two separate trials.

This drug combination demonstrated a favorable safety profile, exhibiting lower liver toxicity compared to other combinations of checkpoint inhibitors and targeted therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frontline Promise for Adagrasib-Pembrolizumab Combination. [2023]

In the CITYSCAPE trial involving 275 patients with chemotherapy-naive, PD-L1-positive non-small-cell lung cancer, the combination of tiragolumab and atezolizumab resulted in a significantly higher objective response rate (31.3% vs. 16.2%) and improved median progression-free survival (5.4 months vs. 3.6 months) compared to placebo plus atezolizumab.

The safety profile of tiragolumab plus atezolizumab was generally similar to that of atezolizumab alone, with serious treatment-related adverse events occurring in 21% of patients in the combination group, indicating that this combination therapy is well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Cho, BC., Abreu, DR., Hussein, M., et al.[2022]

The combination of mogamulizumab and nivolumab was found to be safe and tolerable in a study involving 114 patients with advanced solid tumors, with no dose-limiting toxicities observed during the treatment.

While the treatment showed an objective response rate of 10.5% and a disease control rate of 36.8%, it did not demonstrate enhanced efficacy compared to existing treatments, with median overall survival of 9.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mogamulizumab in Combination with Nivolumab in a Phase I/II Study of Patients with Locally Advanced or Metastatic Solid Tumors. Hong, DS., Rixe, O., Chiu, VK., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

An Anti-TIGIT Antibody with a PD-1 Inhibitor Shows Promise in Solid Tumors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Frontline Promise for Adagrasib-Pembrolizumab Combination. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mogamulizumab in Combination with Nivolumab in a Phase I/II Study of Patients with Locally Advanced or Metastatic Solid Tumors. [2023]