RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

Browse trials for

• Alcoholism 1,603
• Obesity 6,237
• Overweight 3,640

Keywords

• Pemvidutide
• GLP-1 receptor agonist
• Alcohol Use Disorder
• Obesity
• Overweight
• AUD treatment
• Phase 2

Study arms

• Experimental
  Pemvidutide 2.4 mg

  Drug: Pemvidutide

• Placebo comparator
  Placebo

  Other: Placebo

Interventions

• DrugPemvidutide

  Pemvidutide 2.4 mg SC once weekly

• OtherPlacebo

  Placebo SC once weekly

Primary outcomes

1. Change from baseline in the average number of heavy drinking days per week

   Change from baseline in the average number of heavy drinking days per week, with a heavy drinking day defined as 5 or more drinks in the day for men and 4 or more drinks in the day for women, using the Timeline Followback (TLFB) method

   Time frame: Baseline to Weeks 21-24

Secondary outcomes

1. Proportion of subjects achieving a 2-level reduction in WHO risk drinking level

   Proportion of subjects achieving a 2-level reduction in WHO risk drinking level using the TLFB method for the 4-week period comprising Weeks 21 through 24

   Time frame: Baseline to Weeks 21-24

2. Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24

   Time frame: Baseline to Week 24

3. Change from baseline in average number of drinks per drinking day

   Change from baseline in average number of drinks per drinking day using the TLFB method for the 4-week period comprising Week 21 through 24

   Time frame: Baseline to Weeks 21-24

4. Change from baseline in proportion of subjects achieving no heavy drinking days

   Change from baseline in proportion of subjects achieving no heavy drinking days using the TLFB method for the 4-week period comprising Week 21 through 24

   Time frame: Baseline to Weeks 21-24

5. Change from baseline in average percent days completely abstinent

   Change from baseline in average percent days completely abstinent using the TLFB method for the 4-week period comprising Week 21 through 24

   Time frame: Baseline to Weeks 21-24

6. Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R)

   Time frame: Baseline to Week 24

7. Change from baseline at Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Negative Alcohol Consequences (NECO) Short Form

   Time frame: Baseline to Week 24

8. Percent changes from baseline in body weight

   Time frame: Baseline to Week 24

9. Percent change from baseline in BMI

   Time frame: Baseline to Week 24

10. Percent change from baseline in waist circumference

    Time frame: Baseline to Week 24

Individual participant data

Plan to share: Yes — It is anticipated that the results of this study will be presented at scientific meetings and/or published in a peer reviewed scientific or medical journal. A Publications Committee, comprised of the Investigators participating in the study and representatives from the Sponsor, as appropriate, will be formed to oversee the publication of the study results, which will reflect the experience of all participating study centers. Subsequently, individual Investigators may publish results from the study in compliance with their agreement with the Sponsor.