Evaluating TERN-601 for treating overweight and obesity in adults
A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity
PHASE2 · Terns, Inc. · NCT06854952
This study is testing a new pill called TERN-601 to see if it can help adults who are overweight or obese lose weight safely and comfortably.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Terns, Inc. (industry) |
| Locations | 17 sites (Birmingham, Alabama and 16 other locations) |
| Trial ID | NCT06854952 on ClinicalTrials.gov |
What this trial studies
This Phase 2a clinical trial is a multicenter, randomized, double-blind, placebo-controlled study aimed at assessing the efficacy, safety, and tolerability of TERN-601, an orally administered medication, in adults with overweight or obesity. Participants will be randomly assigned to receive either TERN-601 or a matching placebo. The study will focus on individuals with specific body mass index (BMI) criteria and will monitor their health outcomes over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a BMI between 27 and 50 kg/m², particularly those with weight-related comorbidities.
Not a fit: Patients with diabetes mellitus, those whose obesity is induced by medication or other endocrine disorders, or individuals with a history of suicide attempts may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new oral option for managing overweight and obesity, potentially improving health outcomes for patients.
How similar studies have performed: Other studies involving GLP-1 receptor agonists have shown promise in treating obesity, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria:
1. Female or male aged 18 to 75 years
2. Body mass index (BMI) of:
1. ≥ 30 kg/m\^2 to \< 50 kg/m\^2
OR
2. ≥ 27 kg/m\^2 to \< 30 kg/m\^2 with at least 1 weight-related comorbidity
3. HbA1c \< 6.5%
4. Stable self-reported body weight for at least 3 months prior to study (\< 5% body weight gain or loss)
Key Exclusion Criteria:
1. Have diabetes mellitus
2. Have obesity induced by medication or other diagnosed endocrinologic disorders
3. Have had or are planning surgical treatment or device-based therapy for obesity
4. Lifetime history of suicide attempt
Where this trial is running
Birmingham, Alabama and 16 other locations
- FALCON Research Site — Birmingham, Alabama, United States (RECRUITING)
- FALCON Research Site — Homewood, Alabama, United States (RECRUITING)
- FALCON Research Site — Tucson, Arizona, United States (RECRUITING)
- FALCON Research Site — Spring Valley, California, United States (RECRUITING)
- FALCON Research Site — Port Orange, Florida, United States (RECRUITING)
- FALCON Research Site — Louisville, Kentucky, United States (RECRUITING)
- FALCON Research Site — Marrero, Louisiana, United States (RECRUITING)
- FALCON Research Site — Boston, Massachusetts, United States (RECRUITING)
- FALCON Research Site — Rochester, Minnesota, United States (RECRUITING)
- FALCON Research Site — Saint Peters, Missouri, United States (RECRUITING)
- FALCON Research Site — Beachwood, Ohio, United States (RECRUITING)
- FALCON Research Site — Medford, Oregon, United States (RECRUITING)
- FALCON Research Site — Dallas, Texas, United States (RECRUITING)
- FALCON Research Site — Houston, Texas, United States (RECRUITING)
- FALCON Research Site — San Antonio, Texas, United States (RECRUITING)
- FALCON Research Site — Saint George, Utah, United States (RECRUITING)
- FALCON Research Site — Arlington, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@ternspharma.com
- Phone: 650-525-5535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overweight or Obesity, overweight, obesity, obese, glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist, GLP-1