Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 (NCT NCT06019559)
NCT ID: NCT06019559
Last Updated: 2025-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
13 weeks
Results posted on
2025-02-26
Participant Flow
Participant milestones
| Measure |
Placebo to K-757 and K-833
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
K-757 120 mg BID and matching placebo to K-833. Both Administered orally.
|
K-757+K-833
K-757 120 mg BID and K-833 100 mg BID. Both administered orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
52
|
|
Overall Study
COMPLETED
|
43
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
8
|
Reasons for withdrawal
| Measure |
Placebo to K-757 and K-833
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
K-757 120 mg BID and matching placebo to K-833. Both Administered orally.
|
K-757+K-833
K-757 120 mg BID and K-833 100 mg BID. Both administered orally.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833
Baseline characteristics by cohort
| Measure |
Placebo to K-757 and K-833
n=52 Participants
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 Participants
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 Participants
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 9.93 • n=99 Participants
|
50.6 years
STANDARD_DEVIATION 14.84 • n=107 Participants
|
49.0 years
STANDARD_DEVIATION 11.90 • n=206 Participants
|
48.9 years
STANDARD_DEVIATION 12.37 • n=7 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
105 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
126 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
130 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
155 Participants
n=7 Participants
|
|
Weight
|
100.21 kg
STANDARD_DEVIATION 14.426 • n=99 Participants
|
99.36 kg
STANDARD_DEVIATION 13.979 • n=107 Participants
|
100.03 kg
STANDARD_DEVIATION 13.830 • n=206 Participants
|
99.87 kg
STANDARD_DEVIATION 13.994 • n=7 Participants
|
PRIMARY outcome
Timeframe: 13 weeksPopulation: Modified Intent-to-Treat Population
Outcome measures
| Measure |
Placebo to K-757 and K-833
n=52 Participants
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 Participants
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 Participants
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
|---|---|---|---|
|
Percentage Change From Baseline in Body Weight (%) After 13 Weeks of Treatment
|
-0.15 % Change from Baseline
Standard Error 0.562
|
-1.57 % Change from Baseline
Standard Error 0.566
|
-2.94 % Change from Baseline
Standard Error 0.587
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Modified Intent-to-Treat Population
Outcome measures
| Measure |
Placebo to K-757 and K-833
n=52 Participants
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 Participants
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 Participants
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
|---|---|---|---|
|
The Proportion of Participants Achieving ≥5% Weight Loss After 13 Weeks of Treatment
|
6 Participants
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Modified Intent-to-Treat
Outcome measures
| Measure |
Placebo to K-757 and K-833
n=52 Participants
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 Participants
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 Participants
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
|---|---|---|---|
|
Absolute Change From Baseline in Body Weight (kg) After 13 Weeks of Treatment
|
-0.09 kg
Standard Error 0.582
|
-1.64 kg
Standard Error 0.587
|
-3.11 kg
Standard Error 0.609
|
SECONDARY outcome
Timeframe: 15 weeksPopulation: Safety Analysis Set
This outcome is descriptive and no formal statistical analysis was performed.
Outcome measures
| Measure |
Placebo to K-757 and K-833
n=52 Participants
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 Participants
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 Participants
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
|---|---|---|---|
|
Proportion of Participants Who Experienced 1 or More Treatment-emergent AEs
|
31 Participants
|
41 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 13 weeksPopulation: Safety Analysis Set
This outcome is descriptive and no formal statistical analysis was performed.
Outcome measures
| Measure |
Placebo to K-757 and K-833
n=52 Participants
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 Participants
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 Participants
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
|---|---|---|---|
|
Proportion of Participants Who Discontinued Study Medication Due to an AE
|
2 Participants
|
9 Participants
|
14 Participants
|
Adverse Events
Placebo to K-757 and K-833
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
K-757 Alone
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
K-757+K-833
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo to K-757 and K-833
n=52 participants at risk
Matching placebo to K-757 and matching placebo to K-833: Both administered orally
|
K-757 Alone
n=51 participants at risk
K-757 120 mg BID and matching placebo to K-833. Both Administered orally
|
K-757+K-833
n=52 participants at risk
K-757 120 mg BID and K-833 100 mg BID. Both administered orally
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.3%
9/52 • Number of events 9 • 15 weeks
|
29.4%
15/51 • Number of events 15 • 15 weeks
|
51.9%
27/52 • Number of events 27 • 15 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/52 • Number of events 2 • 15 weeks
|
25.5%
13/51 • Number of events 13 • 15 weeks
|
36.5%
19/52 • Number of events 19 • 15 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
13.7%
7/51 • Number of events 7 • 15 weeks
|
23.1%
12/52 • Number of events 12 • 15 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/52 • 15 weeks
|
3.9%
2/51 • Number of events 2 • 15 weeks
|
19.2%
10/52 • Number of events 10 • 15 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
8/52 • Number of events 8 • 15 weeks
|
17.6%
9/51 • Number of events 9 • 15 weeks
|
11.5%
6/52 • Number of events 6 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
7.8%
4/51 • Number of events 4 • 15 weeks
|
5.8%
3/52 • Number of events 3 • 15 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
4/52 • Number of events 4 • 15 weeks
|
5.9%
3/51 • Number of events 3 • 15 weeks
|
7.7%
4/52 • Number of events 4 • 15 weeks
|
|
Infections and infestations
COVID-19
|
5.8%
3/52 • Number of events 3 • 15 weeks
|
2.0%
1/51 • Number of events 1 • 15 weeks
|
5.8%
3/52 • Number of events 3 • 15 weeks
|
|
Nervous system disorders
Headache
|
7.7%
4/52 • Number of events 4 • 15 weeks
|
11.8%
6/51 • Number of events 6 • 15 weeks
|
9.6%
5/52 • Number of events 5 • 15 weeks
|
|
General disorders
Fatigue
|
3.8%
2/52 • Number of events 2 • 15 weeks
|
9.8%
5/51 • Number of events 5 • 15 weeks
|
3.8%
2/52 • Number of events 2 • 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
5.9%
3/51 • Number of events 3 • 15 weeks
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
4/52 • Number of events 4 • 15 weeks
|
5.9%
3/51 • Number of events 3 • 15 weeks
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
5.9%
3/51 • Number of events 3 • 15 weeks
|
0.00%
0/52 • 15 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/52 • 15 weeks
|
11.8%
6/51 • Number of events 6 • 15 weeks
|
0.00%
0/52 • 15 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
5.9%
3/51 • Number of events 3 • 15 weeks
|
1.9%
1/52 • Number of events 1 • 15 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60