Informed Consent for Injectable MOTS-C

INTRODUCTION

THIS INFORMED CONSENT FOR COMPOUNDED MOTS-C INJECTABLE MEDICATION (THE "CONSENT") SETS FORTH INFORMATION REGARDING THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (THE "MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").

The purpose of this informed consent form is to give you written information about the potential benefits, risks, uncertainties, and alternatives associated with compounded MOTS-C administered by subcutaneous injection, so that you can decide whether to proceed. This material supplements your discussion with your Superpower Healthcare Provider. Please read it thoroughly and ask any questions before signing or starting treatment.

Your Superpower Healthcare Provider will review your medical history, medications, supplements, any available laboratory results, and treatment goals to determine whether treatment may be appropriate. An in-person examination, additional testing, or specialist evaluation may be required. Completing an intake or signing this Consent does not guarantee a prescription.

General Information and Background

MOTS-C is a 16-amino-acid peptide whose sequence is encoded within mitochondrial DNA. Mitochondria are structures within cells involved in energy production. Researchers have studied the body's own MOTS-C and synthetic MOTS-C in relation to cellular stress responses, glucose metabolism, and energy regulation.

The compounded injectable product is a synthetic preparation. The presence of a related peptide in the body does not establish that injecting it is safe. Observational studies measuring naturally occurring MOTS-C, animal experiments, and studies of modified compounds such as CB4211 do not establish the safety or effectiveness of this injectable product.

MOTS-C is not FDA-approved for any medical condition. Improvements in energy, insulin sensitivity, body composition, exercise capacity, or lifespan have not been established for this treatment in reliable human clinical trials. A registered study or a proposed biological mechanism is not evidence that treatment works.

Your Healthcare Provider may discuss a specific symptom, functional goal, or metabolic measure to follow. These are treatment goals, not proven benefits. You may experience no improvement. New or unexplained fatigue, exercise intolerance, or abnormal glucose results require appropriate medical evaluation. MOTS-C must not delay established care.

Compounded MOTS-C Injectable Medication

This Consent covers standalone MOTS-C administered into the fatty tissue beneath the skin. It does not cover injection into a vein or muscle, combination products containing other peptides, or a modified MOTS-C analogue. Any different product or route requires a separate clinical discussion and appropriate consent.

There is no FDA-approved MOTS-C product against which the compounded preparation can be considered an approved generic or equivalent. Compounded medications do not undergo FDA premarket review for safety, effectiveness, or quality. FDA has identified concerns about peptide-related impurities, aggregates, possible immune reactions, and the lack of adequate human safety information for administered MOTS-C. HHS has since adopted the interim policy described below, which does not resolve these safety questions.

Products described as "MOTS-C" may differ in their actual ingredient or chemical form. The HHS policy described below applies only to MOTS-C acetate. The dispensing pharmacy must confirm that the product supplied matches the prescription. An unknown or unverified product is not covered by this Consent and must not be used.

A safe and effective human dose, maximum safe dose, and treatment duration have not been established. Prescribing schedules may reflect clinical convention rather than validated human dose-finding studies. Your prescribed dose, concentration, frequency, injection volume, course length, and planned reassessment date will be provided separately. The pharmacy must provide preparation and administration instructions specific to the formulation supplied.

HHS Enforcement Discretion Policy

MOTS-C is not approved by FDA and is not authorized for sale. Compounded MOTS-C is made available through the Platform solely in reliance on an interim enforcement discretion policy issued by the U.S. Department of Health and Human Services ("HHS") in October 2026. Under that policy, while FDA completes rulemaking on whether MOTS-C may be used in compounding, HHS has stated that it does not intend to take enforcement action against a state-licensed pharmacy or licensed physician that compounds MOTS-C acetate for an individual patient under a valid prescription, subject to conditions that include testing of the ingredient and reporting of serious adverse events. The policy reflects HHS's current enforcement intentions only. It is not an FDA approval or authorization, and it is not a finding that MOTS-C is safe or effective.

HHS may revise or rescind the policy at any time, in whole or in part, including if a safety signal or product-quality issue arises. The policy will also be superseded by FDA's final rule, which may not permit MOTS-C to be used in compounding. State laws may further limit availability. As a result, Superpower and the Medical Groups cannot guarantee continued availability of MOTS-C, and your treatment may need to stop before your planned course is complete, with little or no notice. A prescription or signed Consent does not guarantee that MOTS-C can be lawfully compounded or dispensed to you.

Side Effects Risks and Complications

Every treatment involves risk. For administered MOTS-C, adequate human safety data are lacking, so the frequency and full range of side effects are unknown. It is not possible to provide a reliable list of "common" MOTS-C side effects or estimate the likelihood of serious harm. An absence of reported problems does not establish safety.

Possible Injection Effects and Symptoms to Report

• Injections can cause pain, burning, redness, itching, swelling, bruising, bleeding, or a lump at the injection site. Poor technique can cause infection or tissue injury. A larger injection volume may increase local discomfort.
• Report new headache, unusual fatigue, nausea, dizziness, sleep disturbance, appetite changes, or worsening exercise tolerance. These are symptoms to monitor; they are not established common effects of MOTS-C.
• Report shakiness, sweating, sudden hunger, palpitations, confusion, unusual weakness, or low glucose readings. These can be signs of low blood sugar and require prompt action, even though the frequency and degree of glucose effects from MOTS-C in humans are unknown.

Tell your Healthcare Provider about new symptoms even if you are unsure they are related. Do not assume that an adverse symptom means treatment is working.

Possible Drug Interactions

Formal human interaction studies are lacking. MOTS-C may interact with prescription medications, nonprescription products, supplements, or other peptides in ways that are not yet understood.

• Glucose-lowering medications: Disclose insulin, sulfonylureas such as glipizide or glimepiride, metformin, GLP-1 or GIP/GLP-1 medications such as semaglutide or tirzepatide, and SGLT2 inhibitors such as empagliflozin or dapagliflozin. Animal findings raise concern about additional glucose lowering; the size and likelihood of this effect in humans are unknown.
• Recent medication use: If you currently take, or have taken within the preceding three months, metformin, a GLP-1 or GIP/GLP-1 medication, or an SGLT2 inhibitor, do not begin MOTS-C until your Healthcare Provider has reviewed that history and confirmed eligibility under the clinical protocol. This lookback is a screening precaution, not a proven safe washout interval or an instruction to stop medication.
• Insulin and sulfonylureas: These medicines independently carry a risk of low blood sugar. Do not begin MOTS-C while using them without an explicit clinician decision, a glucose-monitoring plan, and instructions for responding to low readings or symptoms.
• Folate and supplements: Disclose folic acid, methylfolate, B-complex supplements, and prenatal vitamins. Laboratory research suggests folate can alter some MOTS-C-related effects, but the clinical significance is unknown. Do not stop prescribed folate or other medically necessary supplements to pursue MOTS-C.
• Disclose all other medicines and peptides. Do not stop or reduce effective diabetes or weight-management treatment to become eligible for MOTS-C, and do not add another product without clinician review.

Potential Serious Side Effects and Complications

• Severe allergic reactions. MOTS-C or another ingredient could cause a serious reaction, including anaphylaxis, with swelling, difficulty breathing, or collapse. The frequency is unknown.
• Immune reactions and possible interference with the body's own peptide. Your immune system may react to the injected peptide, impurities, or aggregates. Antibodies could potentially interfere with the body's own MOTS-C as well as the injected product. Whether this occurs in people, and its consequences, are unknown. Routine laboratory tests cannot rule out this risk.
• Low blood sugar and other metabolic changes. Based on animal and laboratory findings, MOTS-C could affect glucose regulation or insulin sensitivity. Human effects and interaction risks are not established. Low blood sugar from any cause can lead to confusion, falls, seizures, loss of consciousness, or other serious harm. Fasting, missed meals, intense exercise, and glucose-lowering medication may complicate recognition or management of symptoms.
• Infection and product-quality problems. Contamination, an incorrect ingredient or concentration, incomplete dissolution, improper storage, or dosing errors may cause serious injury. Injection-related infection can progress to an abscess or bloodstream infection. Serious infections and severe allergic reactions can be life-threatening.
• Unknown effects on organ function and cell signaling. MOTS-C affects metabolic pathways in experimental models, but its effects throughout the human body are not adequately characterized. Long-term, reproductive, and cancer risks remain unknown. Findings concerning cellular metabolism do not demonstrate that it either causes or prevents cancer.
• Other unknown harms. Unexpected reactions, including serious or lasting harm, may occur with repeated exposure. There is no established safe exposure threshold.
• Delayed diagnosis or treatment. Using MOTS-C in place of an evaluation for fatigue, abnormal glucose, or another symptom, or substituting it for established diabetes or weight-management care, can worsen an underlying condition.

This is not a complete list of possible risks or complications. Following instructions and completing monitoring cannot eliminate all risks.

Contraindications and Additional Information Regarding Potential Risks

Because MOTS-C has no FDA-approved prescribing information, there is no established label-based list of contraindications. The following are precautionary exclusions and requirements for this treatment program.

Do Not Start or Continue Treatment if Any of the Following Apply

• You are under 18 years of age.
• You are pregnant, breastfeeding, or attempting to conceive.
• You have a known allergy to MOTS-C or an ingredient in the dispensed preparation, or have had a serious reaction to a previous dose.
• You have any personal history of cancer, regardless of cancer type, stage, or time since diagnosis or treatment. You must also not start or continue treatment if cancer is suspected, including a new finding being evaluated for possible cancer. Disclose any precancerous condition before treatment.
• You have unexplained or recurrent low blood sugar, or current or recent glucose-lowering medication use that has not been reviewed and cleared under the clinical protocol.
• You cannot verify the medication, concentration, dose, preparation instructions, or injection volume, or cannot safely complete required administration and monitoring.

Pregnancy, breastfeeding, and fertility: Effects on fertility, an unborn baby, and a breastfed infant are not adequately known. If you could become pregnant, discuss effective contraception with your Healthcare Provider. Stop treatment and contact your Healthcare Provider promptly if you become pregnant or decide to attempt conception. No evidence-based preconception washout period has been established.

Before treatment, disclose diabetes, significant liver, kidney, or heart disease, fainting episodes, eating disorders or prolonged fasting, prior bariatric surgery, immune-system conditions, infections, and planned surgery or procedures. These may require additional evaluation, coordination with another clinician, or deferral of treatment. Do not inject through infected, inflamed, damaged, or otherwise abnormal skin.

Competitive sports: MOTS-C is prohibited at all times under the World Anti-Doping Agency Prohibited List, including during and outside competition. A prescription does not automatically exempt you from anti-doping rules. Tell your Healthcare Provider if you participate in a sport or competition subject to testing; use may affect eligibility and result in sanctions.

When to Seek Medical Attention

Stop using the medication and call 911 or seek emergency care immediately for difficulty breathing; swelling of the face, lips, tongue, or throat; collapse or fainting; seizure; severe confusion; inability to swallow safely; chest pain; or sudden weakness or difficulty speaking. Do not wait for a message through the Platform.

If you develop possible low-blood-sugar symptoms, stop activity, do not drive, and check your glucose if a meter is available. Follow the low-glucose treatment plan given by your clinician and seek immediate advice; do not delay treatment because a meter is unavailable. If you are awake and can swallow safely, take a fast-acting source of sugar while obtaining help. Severe symptoms, inability to swallow, or symptoms that do not improve promptly require emergency care. Do not give food or drink to an unconscious person.

Hold further doses and seek prompt medical assessment for low glucose readings or recurring symptoms; a spreading, hot, painful, or draining injection site; fever or chills; a significant rash; persistent vomiting; severe abdominal pain; or a new lump or suspicious skin change. Severe or rapidly worsening symptoms require emergency care.

For other new or persistent symptoms, contact your Healthcare Provider before your next dose. Do not restart after a suspected serious reaction or significant low-glucose episode unless specifically instructed following evaluation.

Under the HHS policy, the compounding pharmacy must report serious adverse events and product-quality issues to FDA and applicable state authorities. You may also report side effects directly to FDA's MedWatch program at www.fda.gov/medwatch or 1-800-FDA-1088.

Alternatives

You may choose not to use MOTS-C or may defer treatment while pursuing further evaluation. Depending on your goals and diagnosis, alternatives may include individualized nutrition, physical activity, resistance training, sleep assessment, treatment of an identified cause of fatigue, and established management of prediabetes or diabetes. FDA-approved weight-management medication or metabolic surgery may be appropriate for eligible patients. Participation in a properly authorized clinical trial may be an option if one is available and you qualify.

Your Healthcare Provider should discuss the expected benefits and risks of alternatives relevant to your condition. MOTS-C is not an established replacement for prescribed diabetes or weight-management treatment, or for evaluation of unexplained symptoms.

Medical History Disclosure Requirements

Provide a complete and accurate medical history, including:

• Current symptoms, diagnosis, prior investigations, surgeries, and treatments tried.
• Diabetes, prediabetes, previous low blood sugar, fainting, or seizure episodes, and any glucose-monitoring results.
• All current and recent glucose-lowering or weight-management medications, including the dates of your last doses.
• Allergies and previous reactions to medicines, injections, preservatives, or other ingredients.
• Any personal history of cancer, regardless of cancer type, stage, or time since diagnosis or treatment; precancerous changes, liver, kidney or heart disease, immune conditions, and infections.
• Pregnancy, breastfeeding, conception plans, and planned procedures.
• All medications, supplements, hormones, and peptides, including folate-containing supplements and products obtained outside Superpower.
• Fasting practices, significant dietary restriction, changes in training, and competitive sport participation.

Keep your Healthcare Provider informed of changes throughout treatment. Withholding or providing inaccurate information can lead to inappropriate treatment and serious harm.

Follow-up and Monitoring

Your treatment plan will identify a symptom, functional goal, or metabolic measure, a reassessment date, and reasons to stop. The protocol includes an asynchronous (online) check-in approximately 2 weeks after starting treatment, followed by asynchronous check-ins every 4 weeks thereafter. Your Healthcare Provider may request an earlier or additional assessment if needed. An end-of-course review is also required. The proposed course is generally 8 to 12 weeks followed by a planned 4-week pause, subject to individual clinical instructions. Neither this schedule nor the pause has been proven to prevent adverse effects or establish long-term safety. Do not restart automatically after the pause.

Treatment may begin before laboratory testing is completed if your Healthcare Provider determines that starting treatment is appropriate. Required laboratory testing must be completed no later than day 60 after starting treatment. Your Healthcare Provider may require testing before treatment or sooner than day 60 if clinically indicated. Monitoring laboratory tests may be requested every 6 months, or at other times as needed, at your Healthcare Provider's discretion. Laboratory results provide information about your general health and may identify reasons to change or stop treatment. Your Healthcare Provider will determine which tests are appropriate; these may include fasting glucose, fasting insulin, HbA1c, lipids, or liver tests. Your Healthcare Provider may require finger-stick or continuous glucose monitoring and additional testing according to your history and symptoms. Review glucose results, sleep, appetite, exercise tolerance, medication changes, and injection reactions at follow-up.

If glucose monitoring is required, do not start until you understand how to use the device, the readings or symptoms that require action, and whom to contact. Serum MOTS-C testing is not an established method to guide this treatment.

Normal laboratory results or favorable wearable data do not establish that MOTS-C is safe, prove that it is effective, or rule out immune reactions or long-term harm. Complete the monitoring requested by your Healthcare Provider. Treatment may be held or stopped for adverse effects, low glucose, significant laboratory changes, a new medical concern, missing monitoring, an unverified product or dose, or lack of meaningful benefit at reassessment. Do not extend a course or increase the dose because improvement has not occurred.

Acknowledgment and Agreement to Proceed

By signing this Consent, I acknowledge the following:

• Understanding and voluntary choice: I have read and understood this information, had the opportunity to discuss my circumstances and alternatives with my Healthcare Provider, and received answers to my questions. I voluntarily consent to the proposed treatment if my Healthcare Provider determines it is appropriate and it can be lawfully provided.
• No FDA approval: I understand that MOTS-C and the compounded injectable product are not FDA-approved for any condition. This involves an unapproved drug substance, rather than simply a different use of an FDA-approved drug.
• Enforcement discretion and availability: I understand that MOTS-C is not authorized for sale, that it is provided solely in reliance on an interim HHS enforcement discretion policy that may be revised or rescinded at any time, and that continued availability is not guaranteed.
• Limited evidence and unknown risks: I understand that the potential benefits are unproven, a safe and effective dose and duration are not established, and serious or long-term risks may be unknown.
• No guarantees: No specific improvement in energy, glucose regulation, weight, body composition, exercise capacity, longevity, or other result has been promised. I understand that a change in symptoms or a laboratory result does not establish long-term benefit or safety.
• Complete medical history: I will accurately disclose my complete medical history, including any personal history of cancer, and all products I use, and promptly report changes, symptoms, pregnancy, or plans to conceive.
• Monitoring and reassessment: I agree to complete required laboratory testing no later than day 60 after starting treatment, or earlier if directed by my Healthcare Provider, and to complete requested follow-up and monitoring tests. I understand that my Healthcare Provider may request monitoring laboratory tests every 6 months or as needed at their discretion, and that continued treatment depends on clinical reassessment, including whether there is meaningful benefit.
• Financial terms: Prescription charges, cancellation, returns, and refunds are governed by the applicable terms disclosed separately. Signing this medical Consent does not itself change those terms.
• Right to decline or stop: I may decline treatment or withdraw consent for future treatment and discuss alternatives with my Healthcare Provider. Signing this Consent does not waive my legal rights or release any party from responsibility for negligent care.

Directions for Use and Following Instructions

• I will follow the written prescription and dispensing pharmacy instructions for the exact product supplied. I will confirm the medication name, ingredients, concentration, dose, injection volume, frequency, and route before the first dose and whenever the prescription or vial changes.
• I understand that milligrams, micrograms, milliliters, and syringe "units" are not interchangeable. Syringe markings measure volume, and the amount of medication at a given marking depends on the concentration. I will not calculate or guess a dose from another product's instructions or an online example.
• I will administer this treatment only by the prescribed subcutaneous route after receiving instructions. I will not inject it into a vein or muscle. If the dose requires more than one injection site, I will follow the exact instructions for the total dose and the volume at each site; I will not improvise the split.
• I will not change the dose, frequency, course length, or formulation without instruction. If I miss a dose, I will follow the provided instructions or contact my Healthcare Provider or pharmacist; I will not double the next dose.
• I will wash my hands, prepare a clean area, use the instructed skin and vial-cleaning technique, rotate approved injection sites, and use a new sterile needle and syringe for each injection. I will never reuse or share injection equipment, vials, or medication.
• I will not mix MOTS-C with other medications or add a diluent unless the dispensing pharmacy specifically directs me to do so and supplies clear preparation instructions. I will not change the concentration to fit the dose into a smaller syringe or use a preparation with unexpected particles or incomplete dissolution.
• I will follow the pharmacy's storage, handling, transport, and preparation instructions and keep the medication out of reach of children and pets. I will use the earlier applicable discard deadline, including the labeled beyond-use date or any shorter period after puncture or reconstitution. I will not assume a universal 28-day rule applies.
• I will not use a damaged, expired, improperly stored, unexpectedly discolored, cloudy, or visibly contaminated product. I will contact the pharmacy if I am uncertain about its appearance, storage, or shipping conditions before injecting it.
• I will follow my individualized glucose-monitoring and low-glucose response plan when required. I will report changes in medication, diet, fasting, or training and will not change those factors to intensify the effect of MOTS-C.
• I will dispose of used needles and syringes in an appropriate sharps container and follow local disposal instructions.
• If I inject the wrong amount or product, I will seek immediate advice from my Healthcare Provider, pharmacist, or Poison Control at 1-800-222-1222. I will seek emergency care for severe symptoms.

CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT

BY SIGNING BELOW, I PROVIDE MY INFORMED CONSENT TO THE PROPOSED TREATMENT WITH COMPOUNDED MOTS-C BY SUBCUTANEOUS INJECTION. I CERTIFY THAT I AM AT LEAST 18 YEARS OF AGE AND AM CONSENTING FOR MYSELF.

I have read this entire Informed Consent, or it has been explained to me in a language I understand. The proposed treatment, uncertainties, potential benefits, risks, and alternatives have been explained to me. I have had the opportunity to ask questions and have received answers satisfactory to me. I understand that I may request a copy of this Consent and withdraw consent for future treatment. I voluntarily elect to proceed, subject to my Healthcare Provider's assessment and applicable prescribing and dispensing requirements.

MEMBER NAME: __________________________________________________

SIGNATURE: ______________________________________________________

DATE: ___________________________________________________________