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NCT02796144: MELT
Metformin and Lorcaserin for Weight Loss in Schizophrenia
Phase 4 trial testing Lorcaserin in Schizophrenia in 71 participants. Terminated before completion.
14 February 2020
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 71 |
| Start date | 1 September 2016 |
| Primary completion | 14 February 2020 |
| Estimated completion | 14 February 2020 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Lorcaserin (LORCASERIN) — full drug profile →
- Metformin (metformin) — full drug profile →
- Placebo
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
- Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
- Overweight — all drugs for Overweight →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Adults 18 to 65, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in Body Weight in Participants Assigned to Lorcaserin/Metformin Combination Treatment and Placebo
Time frame: Baseline, Last Observed Visit (Up to 52 weeks)
Change in body weight in participants assigned to lorcaserin/metformin combination treatment and participants assigned to placebo from baseline to last study visit (up to 52 weeks)
Sponsor's own description
Purpose: The purpose of this study is to test new pharmacologic strategies for weight loss in patients with schizophrenia, a population for which no current weight-loss treatments have gained widespread use. The goal is to recruit overweight people with schizophrenia to participate in a 52-week double-blind, randomized study to assess the efficacy and safety of lorcaserin/metformin combination treatment, lorcaserin monotherapy, and placebo on weight, body composition, and measures of glucose and lipid metabolism. Participants: Approximately 110 subjects will be enrolled at four clinical sites (UNC Chapel Hill, Carolina Behavioral Care, Columbia University, and Augusta University) Procedures (methods): Behavioral: All participants will be offered a behavioral intervention of weekly diet and exercise counseling aimed at modifying cardiovascular risk factors. This intervention will be provided at all in-person study visits after the Baseline Visit and supplemented with weekly interim phone calls to reinforce lessons between visits. Pharmacological Intervention: All participants who meet entry criteria will be randomized to one of the three treatment groups (lorcaserin/metformin, lorcaserin, and placebo).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02796144
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Currently open trials in the same condition.
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Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02796144 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
- Last refreshed: 11 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02796144.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing