Tesomet

What is Tesomet?

Tesomet is the name of the study drug in the Horizon-HO study. It is an experimental drug.

What is an experimental drug?

Experimental means that Tesomet can only be used in clinical research studies because it has not been approved by the US Food and Drug Administration (FDA), or approvers in any country.

How does Tesomet work?

Tesomet is a combination of 2 different active ingredients, tesofensine and metoprolol:

TESOFENSINE

METOPROLOL

Status

Experimental

Approved

Type

Appetite-reducing drug

Blood pressure drug

Reason

May change chemical signaling in the brain to help a person feel less hungry

Lowers blood pressure, which is important because tesofensine can increase blood pressure

Will I receive Tesomet if I join the study?

Participants may or may not receive Tesomet in Part 1 of the study. All participants will receive Tesomet if they participate in Part 2 of the study.

• In Part 1, participants will receive either Tesomet or a placebo (contains no active ingredients) for about 9 months. Participants will be assigned at random (like rolling dice) to one of the following groups:
• Group 1 receives a low dose of the study drug
• Group 2 receives a medium dose of the study drug
• Group 3 receives a high dose of the study drug
• Group 4 receives placebo (no active study drug)
• In Part 1, no one will know which group you are assigned to.
• In Part 2, all participants can extend and receive Tesomet for about 9 additional months.

Have other people used Tesomet?

Yes. Other adolescents and adults have used Tesomet in clinical research studies before this one. Other studies used different dose amounts, and the dose amounts in this study were chosen based on results from past studies.

Before you agree to participate, you can review known side effects of the active ingredients in Tesomet, which will be provided to you in the informed consent form (ICF).