A Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06854952

Acronym

FALCON

Enrollment

167

Registered

2025-03-03

Start date

2025-03-07

Completion date

2025-09-19

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or Obesity

Keywords

overweight, obesity, obese, glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist, GLP-1

Brief summary

This is a Phase 2a multicenter, randomized, double-blind, placebo-controlled clinical trial studying the efficacy, safety, and tolerability of orally administered TERN-601 in adults with overweight or obesity.

Interventions

DRUGTERN-601

Investigational drug

OTHERMatching Placebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Body Weight	12 weeks	Percent change (%) in body weight from baseline to Week 12

Secondary

Measure	Time frame	Description
Change in Body Weight (kg)	12 weeks	Change in body weight (kg) from baseline to Week 12
≥ 5% Weight Loss	12 weeks	Participants achieving ≥ 5% weight loss

Countries

United States

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	21 Participants
Age, Categorical Between 18 and 65 years	146 Participants
Age, Continuous	50.2 Years STANDARD_DEVIATION 13.56
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	38 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	26 Participants
Sex: Female, Male Female	26 Participants
Sex: Female, Male Male	7 Participants
Weight (kg)	101.16 kg STANDARD_DEVIATION 18.075

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 33	0 / 34	0 / 34	0 / 33	0 / 33
other Total, other adverse events	23 / 33	25 / 34	27 / 34	26 / 33	17 / 33
serious Total, serious adverse events	0 / 33	0 / 34	1 / 34	2 / 33	0 / 33

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026