IMM01-STEM for Muscle Loss and Fat Gain

Recruiting at 4 trial locations

Overseen By Joelle Hafen, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Immunis, Inc.

Must not be taking: Corticosteroids, others

Disqualifiers: Diabetes, Severe obesity, Psychiatric disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

55 Participants Needed

Trial Summary

What is the purpose of this trial?

Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness

Research Team

Tom Lane, PhD

Principal Investigator

Chief Science Officer at Immunis, Inc.

Eligibility Criteria

This trial is for men and women aged 60-80 with obesity and muscle weakness. Participants must have a waist circumference of ≥40 inches (men) or ≥35 inches (women), weak grip strength (<16 kg for women, <27 kg for men), slow gait speed (<0.8 m/s), and can have up to two complications related to body composition or muscle function.

Inclusion Criteria

I am either male or female.

I am between 60 and 80 years old.

My race or ethnicity has validated measures for obesity and muscle loss.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment Phase IIa

Participants receive intramuscular injections of IMM01-STEM or placebo twice per week for 4 weeks

4 weeks

8 visits (in-person)

Follow-up Phase IIa

Participants are monitored for safety and effectiveness after treatment, with monthly evaluations

12 weeks

3 visits (in-person)

Interim Analysis and Adaptation

Interim analysis for design adaptation after 10 participants from each group complete treatment

4 weeks

Treatment Phase IIb

Post-adaptation, participants receive the best responding dose or most convenient treatment in a 2-arm placebo-controlled study

4 weeks

Follow-up Phase IIb

Participants continue to be monitored for safety and effectiveness after the second treatment phase

8 weeks

Treatment Details

Interventions

• IMM01-STEM

Trial Overview The study tests the safety and effectiveness of IMM01-STEM on improving muscle performance in seniors with obesity-related muscle weakness. It compares IMM01-STEM against a placebo, with some participants receiving alternating doses of IMM01-STEM and saline as a control.

Participant Groups

Group I: Group 5 Experimental Treatment 1 Intervention

2 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline)

Group II: Group 4 Experimental Treatment 1 Intervention

1 mg total protein in 2 mL final volume twice a week

Group III: Group 3 Experimental Treatment 1 Intervention

1 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline)

Group IV: Group 2 Experimental Treatment 1 Intervention

0.5 mg total protein in 2 mL final volume, twice a week

Group V: Group 1 Placebo Group 1 Intervention

Placebo - 2 mL USP injectable saline, twice a week

Who Is Running the Clinical Trial?

Immunis, Inc.

Lead Sponsor

Trials

3

Recruited

70+