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Setmelanotide for Obesity

LT
Overseen ByLindsay T. Fourman, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
Disqualifiers: Medications affecting endpoints, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators plan to test the efficacy and safey of 6-months of open-label setmelanotide to treat obesity in a single patient with pseudohypoparathyroidism type 1a due to a GNAS mutation.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have PHP1a confirmed by a GNAS gene mutation.
My diabetes and cholesterol are well controlled with treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label setmelanotide for obesity treatment

6 months
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Follow-up assessments at 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Setmelanotide

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patient with pseudohypoparathyroidism type 1aExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

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