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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called IMM01-STEM, designed to improve muscle performance in seniors with obesity and muscle weakness. Participants will receive either the treatment or a placebo (a non-active substance) to evaluate IMM01-STEM's effectiveness compared to no treatment. Suitable candidates for this trial are individuals aged 60 to 80 with both obesity (a large waistline) and sarcopenia (weak muscles). As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants should not have a change in medication for managing conditions like diabetes or hypertension within one month before the screening visit. It's best to discuss your specific medications with the trial investigator.

Is there any evidence suggesting that IMM01-STEM is likely to be safe for humans?

Research has shown that IMM01-STEM has been tested in people before without raising major safety concerns. Earlier studies found that the treatment did not cause issues with body changes or muscle function, indicating it was generally well-tolerated by participants. A few complications were noted, but they were not directly linked to the treatment.

This treatment has also been used in other trials with older adults experiencing muscle loss, which assessed its safety and tolerability. This provides some confidence that IMM01-STEM might be safe for most people.

However, since this trial remains in the early stages, more research is needed to fully understand its safety. The positive news is that the treatment has progressed this far, suggesting it is generally safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about IMM01-STEM for muscle loss and fat gain because it introduces an innovative approach using stem cell-derived proteins, which is different from traditional treatments like resistance training and nutritional supplements. Unlike these standard methods, IMM01-STEM directly targets muscle regeneration by using specific protein dosages to promote muscle growth and reduce fat accumulation. This treatment is administered as an injectable, which allows for precise delivery and potentially faster results compared to oral supplements or lifestyle changes. The varying dosages and frequencies being tested also offer insights into optimizing the balance between efficacy and safety, potentially revolutionizing how we address muscle-related conditions.

What evidence suggests that IMM01-STEM might be an effective treatment for muscle weakness in seniors with obesity?

Research has shown that IMM01-STEM might improve muscle function and metabolism, based on early studies. This trial will evaluate different dosages of IMM01-STEM to help seniors with obesity and muscle weakness enhance their muscle performance. Initial results suggest that IMM01-STEM can increase muscle strength, which is important for everyday activities and overall health. Although most evidence comes from lab research, these findings offer encouragement for those seeking to boost their muscle performance. ^{1 2 4 5 6}

Who Is on the Research Team?

Tom Lane, PhD

Principal Investigator

Chief Science Officer at Immunis, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06600581

NCT06600581 | Safety and Efficacy of IMM01-STEM ... This will be a two-phase, placebo-controlled, dose expansion study that begins with 4 parallel dosing groups and one placebo control group (phase IIa).

2. immunisbiomedical.com immunisbiomedical.com/metabolism/

STEM-META: Targeting Muscle Performance IMM01-STEM benefits muscle function and metabolism (preclinical data). Immunis Scientific Advisory Board member, Professor Micah Drummond, published preclinical ...

3. trialx.com trialx.com/clinical-trials/listings/313199/safety-and-efficacy-of-imm01-stem-against-placebo-on-muscle-performance-in-seniors-with-obesity-and-muscle-weakness/

Safety and Efficacy of IMM01-STEM Against Placebo on ... Overview. Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness ...

4. withpower.com withpower.com/trial/imm01-stem-for-muscle-loss-and-fat-gain-62267

IMM01-STEM for Muscle Loss and Fat Gain Trial Overview The study tests the safety and effectiveness of IMM01-STEM on improving muscle performance in seniors with obesity-related muscle weakness.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05211986

Safety and Tolerability of IMM01-STEM in Patients With ... This will be an open-label, dose escalation study to assess the safety and tolerability of IMM01-STEM, a secretome product derived from partially ...

6. immunisbiomedical.com immunisbiomedical.com/news-media/press-releases/immunis-treats-its-first-patients-for-sarcopenic-obesity/

Immunis Treats its First Patients for Sarcopenic Obesity The Phase 2 trial will assess the safety and tolerability of Immunis' investigational therapy, IMM01-STEM, in older patients with sarcopenia ( ...