Frequently Asked Questions

Use the below list of FAQs to learn more about VANQUISH study topics.

Table of Contents:

• Issuing compliance stipends

• Switching to an autoinjector

• Participant having GI side effects and wants to stop IP

• Participant unhappy with their weight loss

• Participant reached their weight loss goal

• Participant misses doses of IP

• Participant not compliant with study requirements

• No longer collecting PKs after IP discontinuation

• Extension period final protocol timeline

• Participant missed visits, do they still qualify for compliance stipends?

What is the process for issuing compliance stipends?

PCS will manage issuance of compliance stipends. There is no site action needed to enter these stipends. At visits 36, 42, and 48, a $250 stipend will be issued to the participant.

When is my participant eligible to switch to an autoinjector?

Participants can begin switching to the autoinjector when they enter Part B per protocol.

• Part B can initiate on Week 26, Week 30, or Week 34, depending on the Participant’s randomization date.
• Injection training and autoinjector dispensation will only apply to participants that start Part B on Week 26 or Week 30.
• Participants should be trained to dose at least 5 days (120 hours) apart when dosing at home.

What should I tell a participant who is having GI side effects and wants to stop IP?

Discuss that GI-related events are expected for this class of medication. Encourage participants to discuss options to support symptom management prior to discontinuing study treatment.

• Recommend dietary/behavior changes such as smaller, high protein meals or avoiding carbonated drinks and greasy foods.
• If symptoms do not improve, some medications such as antiemetic or antidiarrheal could be prescribed.
• If the patient still has no improvement after the above, consider a temporary interruption of IP for 1 dose. Resume after the single skipped dose.
• If symptoms persist after temporary interruption of IP, consider down-titrating the patient to the previous tolerated dose level.

How should I manage a participant who is unhappy with their weight loss?

• Remind the participant of the benefits that come with the healthy changes they are making.
• Review the realistic weight loss goals and benefits of a slower, steady weight loss.
• Provide perspective of the success they have seen, focus on the positives, and remind them of the study extension opportunity.
• Remind the participant of the lifestyle counseling and monthly meal/gym reimbursement available to them.

How should I manage a participant who has reached their weight loss goal?

• Remind the participant that if they discontinue study participation, there is the possibility that they may regain weight.
• Remind the participant of the extra medical oversight and care they receive throughout the study.
• Congratulate the participant on achieving their weight loss goal and discuss plans for ensuring long-term success.
• Remind the participant of the additional health benefits that may be experienced due to the weight loss. Does the participant have better controlled blood pressure or cholesterol? Are they taking fewer medications? Are they able to participate in more physical activities than beforehand? Focus on the overall health of the participant and the healthy changes they have made throughout the course of the trial, instead of focusing solely on the weight loss.
• If participant’s loved ones are becoming concerned with the amount of weight loss and rapidness in which participants are losing weight, suggest having conversations with loved ones about the health benefits participants have gained since starting the trial. Encourage participants to get their families involved in visits, meal prepping and exercise so the participants feel more supported and their families feel more involved in the changes taking place. Remind family members of the long-term health benefits.

What if a participant misses doses of IP?

• If the participant is having side effects that they have not reported, start treating GI symptoms.
• If the participant is having issues with the injections site, consider use of the arm or leg for injection sites.
• If they are having trouble remembering when to take the IP, help them set reminders in their phone or other convenient place.

What do I do if a participant is not compliant with study requirements?

• Identify the root cause (appointment frequency, travel issues, work conflicts, side effects, etc.).
• Help the participant feel heard with their frustrations. Discuss how you can support them with the challenges they are facing.
• Communicate whether the upcoming visit is a longer one or a shorter one and point out how far they have already come in the study.
• Remind participants of the upcoming transition to monthly visits with the introduction of an auto-injector.

If the subject is off IP but continuing in the study, when do we collect PKs?

Once the study participant is taken off of IP, there is no longer a need to collect PKs.

When can I expect to receive updates on the study extension period?

Protocols for the extension are currently under development. Final drafts are expected to be completed in June 2026.

My participants have missed some visits,do they still qualify for the Visit 36, 42 and 48 compliance stipends?

Yes, participants still qualify for their compliance stipends if they have missed visits. We will proceed with issuing the compliance stipends for Visits 36, 42, and 48 without the requirement for a specific threshold of visit compliance of prior visits. This determination is supported by the current language around visit expectations stated in the protocol, the ICF language, and within the PCS Travel and Reimbursement Policy.