Important Information
DRAFT FOR STUDY AND ETHICS REVIEW — Version 1.2, October 30, 2026. This draft is not ready for participant signature. Before enrollment, the study team must finalize the medication formulation and prescribed instructions, investigator and study-author details, payment and completion-benefit terms, data-sharing details, and applicable study and consent approvals. Saving this text in Efforia does not establish approval.
Summary Information to Help You Decide Whether to Join This Study
INFORMED CONSENT DOCUMENT — AGREEMENT TO BE IN A RESEARCH STUDY
| Study title and number | Beyond Injections: Nasal Semaglutide Impact and Tolerability — Efforia Study 96505 |
|---|---|
| Study team | Efforia study team, working with Superpower. Individual study-author names, the responsible investigator, and the investigator’s contact details must be confirmed in the final consent. |
| Financial support and commercial involvement | The listed participant payment helps cover included products and services. Superpower supplies or arranges study-associated products and benefits. Efforia receives transaction revenue. Final study-specific funding and financial disclosures must be confirmed before enrollment. |
| Listed participant price | US $149. You may already have paid some or all of this amount. The final written terms must explain exactly what this covers and any additional charges before you pay or agree to participate. |
| Associated products and services | Clinician-prescribed nasal semaglutide, listed in Efforia as “Nasal GLP-1 3mg dose”; a Superpower Membership; and a Superpower Marketplace Gift Card. Membership and gift-card access are participation benefits and tokens of appreciation, not additional charges. They are currently configured as study-completion benefits. Their final terms are not yet confirmed. The gift card is for eligible dietary supplements, not prescription drugs. |
| What is measured | Appetite and cravings, participant-reported symptoms and tolerability, and actual medication use or missed doses, using baseline check-ins, the Appetite and Cravings Questionnaire, the Nasal GLP — Symptom Tracker, and daily dose logs. |
| Planned time in the study | 14 days of baseline observations followed by 90 days of treatment observation: about 104 days, with a short final-assessment window through Treatment Day 94 if needed. |
| Study questions or problems | help@efforia.com or Efforia online chat. For medical decisions, contact your prescribing clinician. For participant-rights concerns, contact ethics@efforia.com. |
Introduction and Key Information
You are invited to take part in research on the Efforia platform about people’s experiences while using clinician-prescribed nasal semaglutide. Please read this information and ask questions before deciding. Joining is voluntary. You can refuse or leave at any time without losing ordinary health care or other benefits to which you are entitled.
This study has no role in the prescription decision. Your prescribing clinician independently decides whether to prescribe treatment, which treatment to prescribe, and how it should be used, based on your medical needs and clinical judgment. Your prescribing clinician may decide that the treatment is not appropriate for you or that you are not a good candidate for this study. Joining the study does not guarantee a prescription. The research observes independently prescribed treatment; it does not randomly assign medication, use a placebo, or replace medical care. Do not start, delay, stop, or change medication to match a study task without your prescriber’s advice. You may withdraw from the study and continue treatment according to your prescriber’s care plan.
The compounded nasal formulation is not FDA approved. Its absorption, effect on nasal tissues, effectiveness, and longer-term safety are not established. Evidence about approved injected or oral semaglutide does not establish that this nasal product is safe, equivalent, or effective. A prescription does not remove these uncertainties. Serious side effects and unexpected harms are possible.
You may value tracking your own appetite and symptom patterns and contributing to research. You may prefer not to join because of medication uncertainty, privacy risks, the payment, or repeated questionnaires and logs. You may receive no measurable health benefit. The questionnaires are research measures, not diagnostic tests or a substitute for medical monitoring.
Efforia’s participant-funded model bundles products, services, information, and tracking tools. Paying supports the research experience; it does not purchase a particular result. Ask about costs, alternatives, and refund terms before paying. You can explore other Efforia studies, including any available free options, if this study does not suit your interests or budget.
Purpose of the Study
Some people find injections difficult or prefer a needle-free option. This exploratory study asks whether people using prescribed nasal semaglutide report changes in appetite and cravings and what symptoms or administration difficulties they experience. Semaglutide is a medicine that acts on the glucagon-like peptide-1, or GLP-1, receptor. The nasal spray contains medication and a polymer intended to assist delivery through the nose.
The Appetite and Cravings Questionnaire asks about hunger, fullness, desire to eat, food cravings, eating control, and related experiences. The Nasal GLP — Symptom Tracker asks about nose, sinus, throat, digestive, general, skin, breathing, and other symptoms. These study-specific scores are exploratory and are not established measures of clinical safety or treatment success.
Researchers will describe changes compared with the average of your repeated pretreatment assessments and summarize results across participants. Without randomization, blinding, or a comparison group, the study cannot establish that the medicine caused a change or determine equivalence to approved formulations.
Who May Participate
The planned population is generally healthy adults ages 21–62 seeking modest weight loss or appetite-management support who have independently been prescribed the nasal medicine. Your treating clinician independently assesses whether treatment is appropriate and whether you are a good candidate for this study. The treating clinician may recommend that you do not participate. The study has no role in the treating clinician’s prescription decision, and research participation does not determine your treatment. The final eligibility and clinical screening criteria must be confirmed before enrollment.
What You Will Do as Part of This Study
While participating in this research study, you will need to:
- Be willing and able to follow the study directions and procedures.
- Tell Efforia about side effects or problems through help@efforia.com or online chat, after obtaining any necessary medical care.
- Ask questions as they occur to you.
- Tell Efforia if you change your mind. You may leave at any time by email or chat.
Enrollment includes consent, any applicable payment, contact and personal information, shipping information when needed, and communication preferences. Medical evaluation and prescribing remain the responsibility of the treating clinician.
| Stage | What is planned |
|---|---|
| Baseline: 14 days before treatment observation | Complete the Baseline Appetite and Cravings Questionnaire and Baseline Health and Wellness Check-in at baseline start, Week 1, and Week 2: six questionnaire administrations. Coordinate treatment timing with your clinician; do not postpone medically needed care for research. |
| Treatment observation: 90 days | Follow your own prescription and pharmacy instructions. Use the daily morning and evening logs to record actual use and missed doses. A task title or reminder is not a prescription and does not authorize an extra dose. |
| Treatment Weeks 1–6, 8, 10, and 12 | Complete both the Appetite and Cravings Questionnaire and the Nasal GLP — Symptom Tracker for the period specified in each form: 18 follow-up questionnaire administrations, for 24 in total including baseline. Daily dose logs and check-out are separate activities. Report symptoms and lack of benefit honestly. |
| End of observation | The written study plan calls for check-out around Treatment Day 90 and completion of remaining final assessments by Treatment Day 94. Ask the team for the final schedule and expected time commitment before joining. |
Tell your clinician about all medicines, supplements, and other nasal products you use. Tell the study team about relevant changes in treatment, diet, or other health routines. Medical care takes priority over study completion. Do not guess a dose from the “3mg” product name: the final dispensing label must identify the medicine, concentration, amount per spray, number of sprays, frequency, storage, and what to do after a missed dose.
The current study listing does not establish a required research blood-draw or connected-device schedule. A membership description mentions laboratory testing, but the panel, access arrangements, and membership duration remain to be finalized. Any additional research procedures must be explained and included in the reviewed consent before they occur.
Risks, Discomforts, and Possible Benefits
Research activities may cause inconvenience, fatigue, or discomfort when answering questions about eating, symptoms, or health. Medication-related risks exist even though prescribing occurs separately from research. Risks of the complete nasal blend are not fully known.
Possible Side Effects and Serious Harms
The likelihood of these harms with this particular nasal formulation is unknown. Rates from approved oral or injected products cannot be applied directly to it. The examples below do not include every possible harm.
| Risk | Likelihood with this nasal formulation | What it may involve |
|---|---|---|
| Nose, sinus, and throat effects | Unknown | Burning, irritation, dryness, congestion, nosebleeds, sinus symptoms, altered smell or taste, sore throat, cough, or difficulty swallowing; persistent tissue effects are uncertain. |
| Digestive and general symptoms | Unknown | Nausea, vomiting, diarrhea, constipation, abdominal discomfort, headache, fatigue, or dizziness may interfere with eating, drinking, and daily activities. |
| Pancreas, gallbladder, or kidney injury | Unknown | GLP-1 medicine risks include pancreatitis, gallbladder problems, and kidney injury from dehydration. |
| Severe allergy | Unknown | Hives, facial or throat swelling, or breathing difficulty can require emergency treatment. |
| Low blood sugar and interactions | Unknown | Risk may increase with insulin or some diabetes medicines; delayed stomach emptying may also affect oral medicines. |
| Other important semaglutide risks | Unknown | Approved-product labeling warns about severe digestive effects, diabetic eye complications, increased heart rate, and aspiration during anesthesia or deep sedation. |
| Thyroid tumor warning | Unknown in humans | Semaglutide caused thyroid C-cell tumors in rodents; the relevance to humans is unknown. |
| Additional ingredients and nasal delivery | Unknown | The polymer and other ingredients may cause irritation, allergy, or other effects; variable absorption or spray performance may change exposure. |
| Pregnancy or breastfeeding exposure | Unknown for this formulation | There may be risk to an unborn or breastfed child; discuss pregnancy plans and breastfeeding before any use. |
| Loss of confidentiality | Unknown | Unauthorized access or an unintended disclosure could expose sensitive health or participation information. |
Flushing, palpitations, restlessness, sleep changes, or other symptoms may also occur. Final ingredient-specific counseling is necessary: the current study records do not establish every ingredient or amount. Information about approved semaglutide products provides safety context and does not validate this nasal blend. See the approved-product prescribing information and FDA information about unapproved GLP-1 medicines.
People Who May Be at Increased Risk
Discuss your circumstances with a clinician who knows your health history before joining or using the medicine. This table does not replace final eligibility criteria or medical screening.
| Who needs particular attention | Why |
|---|---|
| People with a personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia type 2 | Approved semaglutide products are contraindicated in these circumstances. |
| People with a previous serious semaglutide allergy or allergy to a blend ingredient | Re-exposure may cause a serious allergic reaction. |
| People who are pregnant, planning pregnancy, or breastfeeding | Potential fetal or infant harm requires clinical counseling; approved semaglutide labeling advises discontinuation at least two months before planned pregnancy. |
| People with pancreas or gallbladder disease, kidney problems, severe stomach-emptying problems, or recurrent vomiting | Some medicine effects may worsen these conditions or lead to dehydration. |
| People using insulin, certain diabetes medicines, another GLP-1 medicine, or medicines whose absorption is important | Low blood sugar, overlapping treatment effects, or interactions require a prescriber’s review. |
| People with diabetic eye disease, significant heart symptoms, nasal disease or injury, recurrent nosebleeds, or other nasal treatments | Existing conditions may complicate medication use or interpretation of symptoms. |
| People planning surgery or a procedure with anesthesia or deep sedation | Tell the procedural care team about semaglutide use because stomach-emptying effects can affect anesthesia safety. |
Consider Your Own Risk–Benefit Comfort Level
Weigh the uncertainty, possible harms, time, cost, and possible value of participating with your clinician. Participant-funded research requires you to make a careful personal choice, while the study team remains responsible for its research duties. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.
Possible Benefits and Findings
You may learn about patterns in your own reports and receive personal outcome reports and overall findings as they become available. Information from the study may help plan future research. There may be no measurable benefit, including no improvement in appetite or weight. A low symptom score cannot establish medication safety. Tell the team if new information changes your willingness to participate.
What to Do About Symptoms or a Study-Related Injury
For an emergency, call 911 in the United States or your local emergency number and seek in-person medical care immediately. Do not wait for a questionnaire, dose log, email reply, or study-team response.
Seek urgent care for severe breathing difficulty, swelling of the face or throat, fainting, uncontrolled bleeding, severe or persistent abdominal pain, repeated vomiting with inability to keep fluids down, or other severe symptoms. Contact your prescribing clinician promptly for new or worsening symptoms and medication advice. Efforia cannot provide emergency treatment or diagnosis.
After obtaining necessary care, report side effects, treatment changes, and injuries to help@efforia.com or online chat so the team can document the event and assess implications for other participants. Study reports and messages are not assured to be reviewed immediately. If you are in a suicide or emotional crisis in the United States, call or text 988; use local crisis services elsewhere.
Injury Care and Compensation
Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.
You or your insurer may be responsible for treatment costs. Ask the study team about any other applicable arrangements before joining. Signing this form does not waive any legal rights or release any person or organization from responsibility for negligence or other legal liability.
Costs, Completion Benefits, and Refunds
The current study price is US $149. Before payment or consent, the team must give you final written terms specifying what the price covers; medication supply, shipping and refill charges; any clinician or laboratory charges; and whether any renewal could create a future charge. No undisclosed additional procedure or purchase is authorized by this draft.
A Superpower Marketplace Gift Card and complimentary Superpower Membership are participation benefits and tokens of appreciation, not additional charges. They are currently configured to become available after completion of follow-up tasks. The gift-card face value, membership duration, fulfillment timing, redemption restrictions, and treatment of partial completion or safety-related withdrawal must be finalized and disclosed before enrollment. The internal product costs do not establish the value you will receive. No cash payment or full reimbursement is promised by this draft.
You can stop research without a withdrawal penalty. Refund eligibility for products or services already supplied is a separate issue. Obtain the applicable written cancellation and refund policy before paying, including what happens if no prescription is issued or treatment must stop. Do not continue medication or conceal symptoms to qualify for a completion benefit.
Alternatives to Participating
You may decline research and discuss ordinary medical care with your clinician, including approved treatment options, non-drug approaches, or no treatment when appropriate. Treatment availability, suitability, and costs outside this study are determined separately. You may also consider another study through Efforia. Refusing this research will not itself affect your ordinary care or benefits to which you are entitled.
Your Rights and Leaving the Study
Your participation is voluntary. You may ask questions, refuse to join, or withdraw at any time for any reason without penalty or loss of benefits to which you are otherwise entitled. You are not giving up legal rights by signing. Contact help@efforia.com or online chat to leave, or use the study’s Leave option if available in your account. The team may ask about symptoms and whether you agree to safety follow-up; you may decline additional research activities.
You may withdraw from this study at any time and continue treatment according to your prescriber’s care plan. Continuing treatment does not require you to remain in the research study. Your prescriber independently decides whether your treatment should continue, change, or stop, based on your medical needs and clinical judgment; the study has no role in that prescription decision. Leaving the study does not itself cancel your prescription or instruct you to stop medication. Discuss ongoing care with your prescriber, and report any treatment changes accurately if you are still providing study information. The investigator may end your participation for safety, ineligibility, inability to follow required procedures, or study closure, and explain appropriate follow-up.
You will be told about significant new information that may affect your decision to continue. You may request a copy of the signed and dated final consent and an explanation of available personal and overall study results.
Privacy, Confidentiality, and Data Protection
Study information includes enrollment and contact details, questionnaire responses, dose logs, symptoms, and relevant health information you provide for the study. Payment and shipping details may also be needed to arrange purchases and fulfillment. Do not send highly sensitive medical records by ordinary email; ask how to share them appropriately.
Authorized Efforia personnel use information for study operations, support, safety review, analysis, and personal reports. Authorized study investigators and analysts may use study data; Superpower and clinical, pharmacy, laboratory, or service providers may need information for their defined roles. Before consent, the final study materials must identify which partners receive identifiable versus coded information and whether clinical or laboratory records will enter the research dataset. A separate authorization may be required for release of clinical records.
Researchers will pool results to describe overall outcomes and use coding or removal of direct identifiers where appropriate. Public reports should not identify you by name. Coded data can still carry a risk of identification. The final consent must explain any planned future research use or sharing beyond this study rather than assuming blanket permission.
Efforia uses confidentiality and access protections, but absolute privacy cannot be guaranteed. Research oversight bodies, the reviewing IRB, and regulators may examine records containing identifying information when authorized. Information may also be disclosed when required by law or to seek local help if there is a serious concern about harm to you or others. Read the Efforia Privacy Policy and ask about any study-specific provisions.
Leaving the study stops your voluntary participation in new research collection. Information already collected may need to be retained and used to preserve research integrity, investigate safety, or meet legal obligations. Contact Efforia about your privacy rights and any request to stop further use; removal of previously analyzed or shared information may not be possible. The final record-retention period and any specific withdrawal limits must be disclosed before enrollment.
Protecting Your Devices and Notifications
Task reminders may be delivered by email and, where enabled and selected, text or push notification. These can reveal participation to someone who sees your screen. Review your communication preferences, protect your devices and accounts with access controls, and avoid sharing passwords. Ask about available notification choices before joining.
Financial Interests and Conflicts of Interest
Efforia receives transaction revenue connected with products and services purchased through its platform. Superpower has a commercial interest in its products and services and may benefit from research findings. The final disclosures must identify study-specific funding, investigator or author financial relationships, and any other relevant interests. The existence of financial interests does not establish that outcomes are favorable or that the nasal product is safe.
Tell the study team before enrollment if you are a study author, employee, investor, or otherwise have a financial relationship with an involved company or measurement provider. The team must assess whether participation is permitted under the final protocol. Honest reports of no change, missed doses, and adverse effects are essential; benefits must not depend on reporting favorable outcomes.
California Experimental Research Subject’s Bill of Rights
Where applicable, California participants are entitled to information in a language they understand about the purpose, procedures, drugs or devices, foreseeable risks, potential benefits, alternatives, and care available for complications. They may ask questions, withdraw without prejudice, receive a copy of the signed and dated consent, and decide freely without force, deception, coercion, or undue influence. The team must provide the required rights document and any applicable acknowledgment before consent. See the California Experimental Research Subject’s Bill of Rights.
Questions, Concerns, and Review Status
For study questions, withdrawal, or reporting a problem after necessary care, contact help@efforia.com or Efforia chat. For medication or medical questions, contact your prescribing clinician using the contact details given with your care.
For questions about participant rights or concerns you prefer to raise outside the immediate study team, contact ethics@efforia.com. An institutional review board, or IRB, reviews research to protect participants’ rights and welfare. This draft does not state that study 96505 has received IRB approval. The final reviewing board, approval record, and responsible investigator’s contact information must be confirmed before enrollment.
Agreement to Participate — For the Final Reviewed Version Only
By signing the final reviewed consent through Efforia’s consent process, I confirm that I have read the information, or had it explained in a language I understand; have had an opportunity to ask questions and received satisfactory answers; understand the study activities, uncertain benefits, medication and research risks, costs, benefits offered, and data uses; and freely agree to participate. I understand that participation is voluntary and that I may leave without giving up my legal rights or ordinary care.
This agreement is to research participation. I understand that the study has no role in prescription decisions, that my prescribing clinician may decide I am not a good candidate for this study, and that I may withdraw from research while continuing treatment according to my prescriber’s care plan. This agreement does not replace clinical treatment consent, a prescription, or any separate authorization required to release medical records. I will receive or can request a copy of the signed and dated final consent.
Participant name, signature, date, and time: to be recorded by the final consent process.
Person obtaining consent, if required: to be recorded by the final consent process.